No Placebo-Only Group

Pivotal Trial

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, 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. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Isotretinoin +/- Immunotherapy for Neuroblastoma

This study is evaluating whether a combination of chemotherapy, isotretinoin, dinutuximab, aldesleukin, and sargramostim is more effective than chemotherapy alone in treating patients with neuroblastoma.

My heart's pumping ability is confirmed to be normal by recent tests.

I have high-risk neuroblastoma, or it became high-risk after initial diagnosis.

I completed therapy for my cancer, including intensive treatment and a stem cell transplant.

My seizures are under control with medication and I have no severe brain-related side effects.

My parent or guardian has given written consent for me to participate.

I am eligible for a second stem cell transplant.

My latest bone marrow tests show less than 10% tumor cells before my stem cell transplant or joining this study.

I started my first chemotherapy for high-risk neuroblastoma less than 12 months ago.

I've had recent scans and tests to check my cancer's stage before joining the trial.

I've completed therapy for neuroblastoma, including intensive treatments and possibly surgery.

I am eligible for a tandem transplant and have followed specific treatment protocols within the last 12 months.

My veno-occlusive disease is stable or getting better.

My lung function tests are above 60% of what's expected, or I'm a child without breathing issues.

My neuroblastoma shows a positive response according to specific criteria before stem cell transplant.

My kidney function is within the required range for my age and gender.

I have never received GD2 antibody therapy.

I can do most activities and my doctor thinks I have at least 2 months to live.

I still have cancer after radiotherapy but haven't had a biopsy.

My neuroblastoma shows a positive response to treatment before stem cell transplant.

My kidney function is normal or near normal.

Aldesleukin

Dinutuximab

Isotretinoin

Sargramostim

This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Radiation + Chemotherapy for Medulloblastoma

This study is evaluating whether standard-dose radiation therapy works better than reduced-dose radiation therapy in treating young patients with medulloblastoma.

I have not had any radiotherapy treatments before.

My cancer, medulloblastoma, is confirmed and located in the back of my brain.

My condition is considered standard-risk.

My remaining cancer is smaller than 1.5 cm^2 and not widespread, confirmed by a recent MRI.

My cancer has not spread to my brain, spine, or cerebrospinal fluid.

I can perform most of my daily activities without help.

My bilirubin levels are within normal range for my age.

My liver enzymes are within normal limits for my age.

Cisplatin

Craniospinal Irradiation

Cyclophosphamide

Involved-Field Radiation Therapy

Lomustine

Radiation Therapy

Vincristine Sulfate

Approved for 50 Other Conditions

This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

Surgery, Radiation & Chemotherapy for Early-Stage Hodgkin's Lymphoma

This study is evaluating whether surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease.

I have been newly diagnosed with LPHD and haven't received any treatment.

My cancer is in the early stage and hasn't grown large.

My cancer is at an early stage and has not formed a large tumor.

I agree not to breastfeed if I receive chemotherapy or radiation.

I am a woman who can have children and have a negative pregnancy test before starting treatment.

I haven't taken systemic corticosteroids in the last 30 days.

My creatinine level is not above 1.5 mg/dL.

I am pregnant or breastfeeding, have stage I cancer with one lymph node involved, and had a complete surgery.

I agree to use effective birth control during my chemotherapy or radiation treatment.

My creatinine level is not above 1.2 mg/dL, and I am between 10 to 12 years old.

My LPHD diagnosis follows specific international standards.

My kidney function is appropriate for my age and gender.

My creatinine level is not above 1.0 mg/dL, and I am between 6 and 9 years old.

My child's creatinine level is not above 0.8 mg/dL.

Conventional Surgery

Doxorubicin Hydrochloride

Prednisone

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.

Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

Chemotherapy + Stem Cell Transplant for Brain Cancer

This study is evaluating whether a chemotherapy regimen is more effective than another in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue.

I haven't had radiation or chemotherapy, only corticosteroids.

My breathing and oxygen levels are stable.

My blood counts meet the required levels.

My child is under 8 months old and has early-stage medulloblastoma.

My diagnosis is a specific brain tumor called supratentorial PNET.

I have anaplastic medulloblastoma, regardless of its spread or remaining tumor.

My medulloblastoma is classic, not desmoplastic, and any remaining disease is smaller than 1.5 cm^2.

My medulloblastoma is considered high-risk.

Autologous Hematopoietic Stem Cell Transplantation

Carboplatin

Etoposide

Filgrastim

Leucovorin Calcium

Methotrexate

Thiotepa

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

Chemotherapy +/− Radiation for Kidney Cancer

This study is evaluating whether chemotherapy and radiation therapy are more effective than observation only for treating patients with Wilms' tumor.

My condition fits into one of the required disease categories.

I have not had chemotherapy or radiotherapy for my tumor.

My condition is considered very low-risk.

I am transferring from AREN03B2 with specific genetic changes.

I have Denys-Drash syndrome or similar urinary tract issues.

My cancer is in the early stage (Stage I).

My heart's pumping ability is within a healthy range.

My lymph nodes do not have cancer, confirmed by a biopsy.

My cancer is in an early to mid-stage (I-III).

I do not have Wilms tumors in both kidneys at the same time.

My genetic test shows no loss on chromosomes 1p and 16q.

My condition is in the early stage (Stage I).

My child can do most activities but may need assistance.

The size of the tumor is greater than 500 grams.

My condition does not need radiation treatment.

I have been diagnosed with Simpson-Golabi-Behmel syndrome.

My early-stage cancer shows specific genetic changes.

Your bilirubin (direct) level should not be more than 1.5 times the upper limit of normal.

You don't have any cancer spread to your lungs as shown on a chest CT scan.

I do not have a high-risk genetic condition for kidney cancer.

My condition is confirmed as Wilms' tumor.

Your liver enzymes (AST or ALT) are not more than 2.5 times the upper limit of normal.

I have a unilateral Wilms tumor without risk factors for developing it on both sides.

My child under 1 year has a specific kidney condition.

You need to have a test that shows you are not pregnant.

I am over 16 and can do most activities without help.

3-dimensional conformal radiation therapy

3-Dimensional Conformal Radiation Therapy

Dactinomycin

Therapeutic Conventional Surgery

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Chemotherapy + Radiation for Kidney Cancer (Wilms' Tumor)

This study is evaluating how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor.

I can perform most of my daily activities without assistance.

Your liver enzymes (AST or ALT) are not more than 2.5 times the normal level.

I haven't had chemotherapy or radiotherapy, except as part of COG-AREN0532 or for urgent medical reasons.

I have been recently diagnosed with Wilms' tumor at a specific stage.

Your bilirubin levels are within a certain range.

I will start treatment within 2 weeks after my surgery or biopsy, unless my doctor advises against it.

Your heart's pumping function is normal, as shown by specific heart tests.

3-dimensional Conformal Radiation Therapy

Liposomal Vincristine Sulfate

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

Chemotherapy + Radiation for Medulloblastoma

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than either treatment alone in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma.

I should be careful with certain kidney-damaging medications.

My cancer has not spread to distant organs (not M4).

I have been newly diagnosed with medulloblastoma and have not received any treatment.

I have a specific type of brain tumor called diffusely anaplastic medulloblastoma.

I am not taking strong drugs that affect liver enzymes.

My seizure medication will be monitored while I receive cisplatin.

I have not had chemotherapy or radiation therapy before.

I am not taking corticosteroids with my chemotherapy.

I have had a brain MRI with contrast before surgery.

My kidney function, measured by creatinine levels, is appropriate for my age and gender.

I have had a head MRI with contrast after surgery.

I have had an MRI of my spine with a special dye.

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Combination Chemotherapy for T-Cell Leukemia/Lymphoma

This study is evaluating whether a combination of drugs is more effective than a single drug in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

My T-NHL does not include specific types like B-precursor lymphoblastic lymphoma or involve the brain/testicles.

I have not had chemotherapy, except for steroids or IT cytarabine.

My leukemia is classified as T-ALL based on specific cell markers.

I have been newly diagnosed with T-ALL or T-NHL at stage II-IV.

I've had IT chemotherapy with cytarabine for convenience before joining.

I have T-NHL or T-ALL and may need steroids before starting treatment, affecting my risk classification.

I've had emergency chest radiation up to 600 cGy for airway issues.

I haven't taken seizure medications or had significant nerve damage in the last 2 years.

Asparaginase

Daunorubicin Hydrochloride

Dexamethasone

Mercaptopurine

Nelarabine

Pegaspargase

Thioguanine

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

AMPLATZER Device for Ventricular Septal Defects

This study is evaluating whether the AMPLATZER Muscular VSD Occluder is safe and effective in people with a muscular ventricular septal defect.

I have a hole in my heart after a heart attack.

I am considered high-risk for standard heart surgery due to my heart's structure.

My heart defect is close to the heart valves.

I currently have an active bacterial infection.

I cannot take anti-platelet medications due to health reasons.

I have a significant hole in the heart muscle wall that needs closing.

My doctor thinks closing the hole in my heart is necessary.

I have severe lung blood pressure issues and irreversible lung vessel disease.

I have a hole in my heart near the aortic valve.

I have an infection that has spread throughout my body.

I have a significant heart shunt, high lung blood pressure, or symptoms of heart failure.

AMPLATZER Muscular VSD Occluder

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Dasatinib for Pediatric Leukemia

I am not using proton pump inhibitors, H2 antagonists, or CYP3A4 modifiers.

I have CML and cannot tolerate or didn't respond to imatinib.

I can do most activities but need help with some.

I have chronic phase CML and am currently taking dasatinib daily as part of this study.

I have previously been treated with imatinib or another TKI therapy.

My cancer is located outside the bone marrow.

I have been treated with Dasatinib before.

I have leukemia and didn't respond well or relapsed after imatinib treatment.

I have just been diagnosed with chronic myeloid leukemia and haven't started treatment.

I have CP-CML and am taking a dasatinib dose of at least 60 mg/m2 or 72 mg/m2.

Seattle Children'S Clinical Trials 2022

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