Search Results Within Category "Cancer"
ACNS1833-A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
This phase 3 trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have a body surface area (BSA) of ≥ 0.5 m2 at enrollment.
Non-neurofibromatosis type 1 low-grade glioma without a BRAFV600E mutation confirmed by Central Pathology and Molecular Screening Reviews performed on APEC14B1, CCDI-MCI, or accepted CLIA-certified test.
Adequate renal, liver, cardiac, and bone marrow function
Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals Grade I/II histology
Patients may not be receiving any other investigational agents
Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of CTCAE Grade 3 or higher immune related adverse events (irAEs).
Consent to treatment, required labs, imaging, and sample collections.
Newly diagnosed AJCC Stage II-IV nasopharyngeal carcinoma (NPC)
Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of ≥ 60%.
Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission
Patients with a diagnosis of immunodeficiency
Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time.
Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias
Primary Aims: 1. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available Phase I/II PedAL sub-trials. 2. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.
Consent to enrollment, required labs and sample collections.
Patient has known or suspected relapsed/refractory (including primary refractory) AML-This includes isolated myeloid sarcoma.
Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
Patient has known or suspected relapsed ALL
Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL)
COG APEC14B1 - Project: Every Child for Younger Patients With Cancer
The next generation of therapy for childhood cancers will be based upon in-depth molecular phenotyping that may facilitate the development of rational risk-adapted and target-based therapies. In order to support current and future molecularly-guided therapeutic trials and the basic science discovery efforts that will lead to more effective therapies, prevention, early detection and a reduction in early and late-onset toxicities, it is critical to implement universal, high-quality collection of annotated biospecimens from children with cancer. This protocol provides for the collection of biospecimens and accompanying demographic, epidemiologic, therapeutic, and outcome data from all children diagnosed with cancer at participating COG institutions, independent of the patient’s enrollment on a therapeutic clinical trial. Through this approach, the correlation of phenotypic and genotypic or other –omic data with the relevant outcomes at the individual, disease, and protocol levels will be ensured. Biospecimen requirements and handling may be disease specific and thus a detailed manual of procedures will provide disease specific information regarding sample collection and processing based on the clinical diagnosis.
Consent to enrollment, eligibility screening and sample collections.
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.
All cancer cases with an ICD-O histologic behavior code of one “1” (borderline), two “2” (carcinoma in situ) or three “3” (malignant).
All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
ACNS2021 - A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular &Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology
and/or serum or CSF elevation of AFP above institutional normal or > 10 ng/mL or hCGβ > 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS.
Disease/Staging Imaging
CSF Cytology and tumor markers
Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
Pregnancy and Breastfeeding
ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
The study involves taking the drug levocarnitine during standard of care chemotherapy. The overall goal of this study is to determine whether taking levocarnitine will reduce the rate of severe liver damage caused by asparaginase chemotherapy during the first month of treatment.
Consent to treatment, required labs, sample collections, and completion of surveys.
Diagnosis: Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL) Note: PH+ and PH-like acute leukemia are eligible (use of TKI or CRLF2-targeted concomitant medication must be documented, if used)
Adequate liver function
Adequate renal function
Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille Syndrome, primary sclerosing cholangitis, other)
Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig ≥ Stage 3)
Unable to tolerate oral formulation of study drug at enrollment
Patients who received chemotherapy or treatment for a prior malignancy are not eligible
AREN1921:Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Consent to treatment, required labs, sample collections, and imaging.
Enrollment on APEC14B1
Newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure
Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
Patients with Renal Tubular Acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate ≤ 2 mg/dL (or < 0.8 mmol/L) without supplementation
Umbrella Long Term Follow Up Protocol (COG ALTE05N1)
Umbrella Long Term Follow Up Protocol (COG ALTE05N1)
Consent to enrollment and eligibility screening and completion of surveys and/or questionnaires.
or The patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1
The patient must reside in the U.S. on the date of enrollment to ALTE05N1
COG AALL1621 - Inotuzumab Ozogamicin in Treating Younger Patients With Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
This Phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients must have B-ALL, or previously diagnosed B-LL, with ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease.
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
Patients with isolated CNS, testicular, or any other extramedullary site of relapse.
Patients who have been previously treated with inotuzumab ozogamicin.
History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study.
Patients with active optic nerve and/or retinal involvement are not eligible. Patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, an MRI to assess optic nerve or retinal involvement.
ANBL1531 Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial).
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
The overall goal of this study is to compare the effects, good and/or bad, of two different surgery methods for people with OST that has spread to the lung to find out which is better. In this study, participants will receive 1 of 2 treatment plans. Treatment with open surgery is the older standard therapy for people with OST that has spread to the lung. Treatment with VATS is a newer method that has also been shown to work when used to treat the same type of cancer
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Patients must have a histological diagnosis of osteosarcoma
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
Patients with evidence of extrapulmonary metastatic disease
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. N
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory, or Progressive Neuroblastoma
This phase II trial studies how well irinotecan hydrochloride (irinotecan), temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back or that isn't responding to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines, at the time of initial diagnosis
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age.
Patients must not have received prior treatment with irinotecan and temozolomide.
Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
Patients with symptoms of congestive heart failure are not eligible.
Patients must not have uncontrolled infection.
AALL1732 Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.
Consent to treatment, required labs, sample collections, and imaging.
B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to Eligibility studies (Part A) prior to treatment and enrollment on AALL1732.
White Blood Cell Count (WBC) Criteria
Patient has newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with ≥25% blasts on a bone marrow (BM) aspirate
A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
Patients with Acute Undifferentiated Leukemia (AUL) are not eligible
Patients requiring radiation at diagnosis.
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients in Group F must have a BSA ≥ 0.6 m2 .
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection.
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplaitin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Standard Risk 1 Patients must be < 11 years of age at enrollmen
Standard Risk 2 Patients must be ≥ 11 and < 25 years of age at enrollment
Patients enrolling on one of the Low Risk arms must be newly diagnosed with a Stage I germ cell tumor. For the Standard Risk arms, patients must be newly diagnosed with metastatic germ cell tumor (Stage II or higher).
Patients must have a performance status corresponding to ECOG scores of 0, 1, 2 or 3. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age
Pure dysgerminoma
Pure mature teratoma
ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
Consent to treatment, required labs, sample collections, and imaging.
Patients must be ≤ 21 years at the time of enrollment
Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy
Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment
Patients unable to undergo radiation therapy, if necessary, as specified in the protocol
Evidence of uncontrolled infection
PSCI #25-020 NRG-CC013: A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation with BMX-001 in Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
This trial will examine the usual symptom management chemoradiation with or without BMX-001.
Participants must agree to come to all study visits. Participants will be coming to the clinic at least twice a month for treatment. After treatment is finished, you will be followed every three months to see how you are doing
Zubrod Performance Status of 0-2
Patients must have adequate health that permits completion of the study
Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy.
Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
Age < 18
prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer
current treatment of adjuvant post-op chemoradiation
A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors
In this multi-site, parallel-group, randomized clinical trial, we will evaluate the efficacy of BRIGHT, a novel psychological intervention for cancer survivors, compared with attention control (AC) for managing body image distress (BID) among head and neck cancer survivors (HNC) survivors, examine BRIGHT’s underlying mechanisms, and characterize factors affecting the future adoption of BRIGHT into clinical care.
1. The researchers will check your medical records to gather information about your diagnosis and treatment. 2. You will meet with the study coordinator to fill out baseline questionnaires. 3. You will be randomly assigned to one of two groups. This means that you have a 50/50 chance (like flipping a coin) of being in either group. Neither the researchers nor you will make the choice to which group you are assigned. 4. Cognitive behavioral therapy involves meeting with a study psychologist to identify and address unhelpful automatic thoughts that may contribute to unwanted behaviors. The cognitive behavioral therapy group will meet with one-on-one with the study psychologist once per week for six weeks, using a video telemedicine platform. Each visit with the psychologist will take one hour. An attention control group is one that receives the same amount of attention as the intervention group but without the potential active ingredient. The attention control group will meet with one-on-one with a head and neck cancer clinician once per week for six weeks, using a video telemedicine platform to receive survivorship education. Each visit with will take one hour. These sessions will be video-recorded to help ensure that the interventionist delivers each intervention as intended. 5. Regardless of whether you are in the cognitive behavioral therapy or attention control group, you will meet with the study coordinator at the end of the study to complete questionnaires to measure changes compared to baseline and describe your experience in the study.
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Completion of cancer treatment within 12 months of study enrollment
Cancer-free at time of accrual
No planned significant head and neck surgery
Willingness to complete 6 weekly educational or therapeutic sessions
Currently receiving ongoing psychotherapy services
Initiation or adjustment of psychotropic medications within the last 3 months
Mental illness diagnosis that would prevent trial participation
AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors
Germ Cell Tumors (GCTs) are sorted in “risk groups” that describe how much the tumor has grown in the body. The three “risk groups” are: good, intermediate, and poor. For this study, we are interested in learning more about intermediate and poor-risk GCTs, also known as “advanced” GCTs. A research study is when doctors work together to try out new ways to help people who are sick. In this study, we are trying to learn more about how to treat GCTs. Standard treatment for advanced GCTs is chemotherapy (anti-cancer drugs). Some of the drugs used may cause bad effects that show up during treatment. This study will compare the standard way to treat GCTs with the same type of treatment, but delivered over a shorter amount of time (called “accelerated” treatment). This will help us understand if the accelerated treatment is better but not more harmful than the standard treatment. We will do this by closely watching to see if the cancer grows or spreads. We do not know which treatment will be better, which is why we are doing this study.
Consent to treatment, required labs, sample collections.
Histologically or cytologically confirmed germ cell tumor OR exceptionally raised tumor markers without histologic or cytologic confirmation
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Metastatic disease or non-testicular primary.
Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
Peripheral neuropathy ≥ Grade 2 or clinically significant sensorineural hearing loss or tinnitus
Known allergy or hypersensitivity to any of the study drugs.
EA5221: A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable older adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study
This study is being done to answer the following question: Does adding chemotherapy to immunotherapy versus immunotherapy alone help older patients with lung cancer live longer while also maintaining a good quality of life? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your lung cancer. The usual approach is defined as care most people get for lung cancer.
If the participant decide to take part in this study, they will either get pembrolizumab alone until disease progression, or chemotherapy from study-provided list of allowable choices combined with pembrolizumab for up to 2 years or until disease progression. After the participant finishes study treatment, the study doctor will continue to follow their condition for 5 years from the date of registration for survival. The participant will be followed every 3 months < 2 years from registration, and every 6 months for years 2-5.
Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-RT for stage III with recurrence is allowed.
Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors.
Patient must have an ECOG Performance Status of 2.
Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment.
AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. In Part 1 of the study, we will find out the highest dose of cabozantinib that can be given in combination with MAP without causing side effects that are too severe. In Part 2, subjects will either receive a combination treatment of MAP with cabozantinib or MAP alone
At the start of the study and during treatment, patients will have blood drawn to check the levels of hormones from their thyroid and proteins that are made by the pancreas. Patients will also have the protein levels checked in their urine. The protein levels in the urine will be checked. In addition, patients' blood pressure will be monitored more often than usual because they are taking cabozantinib on this study.
Patients must have a body surface area of > 0.8 m 2 at the time of enrollment
Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma
Patients who have central nervous system metastases.
Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
PSCI 25-051 NRG-GU014: Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC TRIAL)
This study will look to see if radiation plus immunotherapy is better than radiation and chemotherapy.
The participant will either get chemotherapy and radiation therapy for up to 4-7 weeks, or they will get radiation therapy for 4-7 weeks plus the immunotherapy drug, pembrolizumab, given every 6 weeks for about one year (for a total of 9 doses). After the participant finishes the study treatment the study doctor will continue to follow their condition for almost 10 years, either by telephone or clinic visit, and watch them for side effects. The study doctor will monitor the participant every 3 months for 2 years, then every 6 months for 3 years and then annually for 5 years.
Age ≥ 18
Not Pregnant and Not Nursing
Patients must have recovered from acute cardiac illness
No glucocorticoids
PSCI# 25-079 NRG-CC015: Harnessing E-Mindfulness Approaches For Living-After Breast Cancer---HEAL-ABC
This study is comparing 3 arms, one in which patients will participate in Mindfulness (MAPs) Live Online. One in which patients will participate in Mindfulness (MAPs) digitally and one in which patients will participate in the control group, which is meditation only.
Screening visit will be in person. Patients will complete up to 3 hours per week of the assigned activity over a 6-week period. Participation in this study will last about 9 months.
The participant must have been ≥ 18 or <51 years of age at the time of breast cancer diagnosis.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
The participant must have a score of ≥ 5 and ≤ 14 on the Patient Health Questionnaire-8 item (PHQ-8).
The participant must be able to understand, speak, read, and write in English or Spanish.
Any history or current evidence of recurrent or metastatic breast cancer.
Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Currently pregnant or planning to become pregnant in the near future.
Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
PSCI# 25-059: Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer – A Randomized Phase 3 Trial
The purpose of this study is to compare the usual approach to a new technique in radiotherapy delivery called stereotactic body radiotherapy (SBRT) while continuing the current treatment of immunotherapy with or without chemotherapy.
Participants will meet with the study team to discuss the study. After it has been determined that is save for them to enroll, they will need to attend all appointments. Participants will be coming to the clinic at least monthly for infusion therapy and daily for radiation. It is important that participants let the study team know how they are feeling.
Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles
All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy
ECOG performance status of 0, 1 or 2.
Participants must be ≥ 18 years of age.
Pregnancy
Serious medical conditions in which radiotherapy of target lesions is contraindicated
Participants who are not actively on ICI alone or ICI + chemotherapy.
Concurrent treatment with other anti-cancer therapy, including investigational agents.
AREN2231: Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
The purpose of this study is to improve the treatment of children and young adults with all stages of FHWT, so that more patients are cured without relapse, and that side effects from treatment are lessened without decreasing cure rates. This study will use information on higher or lower risk features of FHWT to adjust the treatment of each subject based on their risk of relapse.
All patients will receive chemotherapy (regardless of stratum assignment) starting with 1 cycle (3 weeks) of VA (vinCRIStine, DACTINomycin) chemotherapy. Some patients will have changes in treatment based on information learned after enrollment. For all patients, at least one callback is required to be completed prior to randomization and/or prior to any change in treatment or continuation of the same treatment.
Patients must have newly diagnosed Stage I-IV Favorable Histology Wilms Tumor
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
Patients with known Charcot-Marie-Tooth syndrome
Patients receiving concurrent chemotherapy for a different diagnosis.
PSCI 23-146 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
this trial will compare Pembrolizumab with and without MK-2870 in participants with lung cancer for disease free survival.
Participants will be required to com to all study visits, report all medications they are taking, including over the counter medications and tell the study team how they are feeling.
$50 for each completed visit
Able to undergo surgery based on opinion of investigator after consultation with surgeon.
Able to receive pembrolizumab and platinum-based chemotherapy
Has not achieved pathologic Complete Response at surgery
18 years of age
Has history of documented severe dry eye syndrome,
Has active inflammatory bowel disease
Has active inflammatory bowel disease
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
This study is being done to answer the following question: Does the use of Olaparib for one year keep your ovarian cancer from growing or returning as well as the usual approach of two years? If you decide to take part in this study, you will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until your disease gets worse or the side effects become too severe. After you finish your treatment, your doctor and study team will watch you for side effects. They will check you every 3 months for 2 years after treatment. After that, they will check you every 6 months for 3 years. This means you will keep seeing your doctor for 5 years after treatment.
The patient will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until their disease gets worse or the side effects become too severe. The doctor and study team will watch for side effects. They will check every 3 months for 2 years after treatment. After that, they will check every 6 months for 3 years. This means checking with the doctor for 5 years after treatment.
high grade serous, high grade endometrioid, and/or other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic).
Patients must have: 1) Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration).
OR 2) BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory (e.g., Myriad MyChoice©)
Patient must have undergone cytoreductive surgery (primary or interval).
PSCI 24-076 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) (IDeate-Esophageal01) (A PHASE 3 STUDY OF I-DXD IN SUBJECTS WITH PRETREATED ESCC)
This trial will be examining the use of a drug, ifinatamab in the treatment of patients with advanced or metastatic esophageal squamous cell cancer.
After signing consent, participants will have blood tests and scans to see if they are well enough to participate. If the participate, they will need to come to the clinic to see the study team then get the experimental treatment. Participants will continue treatment until the medication no longer works, they no longer want to participate, or the study doctor feels it is not safe for them to continue.
Has histologically or cytologically documented unresectable locally advanced (Stage II to IVA if T2-T4 or N1-3 M0), or metastatic (Stage IVB) ESCC
Has disease progression post platinum-based and ICI treatment
Has received any topoisomerase inhibitor.
Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
PSCI # 25-038 A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This trial will examine which combination is better in treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Sorotoclax or Venatoclax.
There are three parts to this study. Screening, when you will meet the study team, sign the consent for and have tests performed to make sure that it is safe for you to participate in the study. If you join the study you will be chosen to participate in one of four arms, each with different medication to treat you disease. During the first cycle of treatment you will need to be seen by the study team between 4 and 7 times, depending upon the treatment. You will continue on the study medication until it no longer works, you have finished the trial or the doctor feels that it is no safe for your to continue ( among other reasons). The third part of the study is follow up. you will have a study visit in the clinic 30 after the last day of taking the study drug. That will be followed by after treatment follow up visits every three months until your cancer returns, if it returns. Then you will be followed every three months to see how you are doing.
Must have confirmed diagnosis of CLL/SLL
Must have received ≥ 1 prior therapy for CLL/SLL
Must not have received any maintenance therapy.
Patients with a history of confirmed progressive multifocal leukoencephalopathy
Prior allogeneic stem cell transplant with active GVHD
Received a live, attenuated vaccine within 4 weeks
PSCI# 25-001 TITLE PAGE A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
This study is comparing using rilvegostomig or pembrolizumab with a platinum based chemotherapy. The doctor, subject and study team will not know if the subject is receiving rilvegostomig or pembrolizumab.
After signing consent to agree to join the study, the subject will have lab work and scans of their body to see if they are wll enough to participate. If they begin study treatment, they must come to all study visits. It is important that the subject tell the study team if there has been a change in their medications and how they are feeling. Subjects will continue treatment until the treatment no longer is working, they no longer want to participate of the study doctor feels it is not safe for them to participate any further. Once study treatment is finished, subjects will be followed to see how they are feeling and what new treatments for their cancer they are getting.
$75.00 for each visit completed for a minimum of $300. Compensation may be more if additional visits are completed.
Histologically or cytologically documented squamous NSCLC
Minimum life expectancy of 12 weeks
Minimum body weight of 30 kg.
History of organ transplant
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.