Chemotherapy + Stem Cell Transplant for Brain Cancer

Recruiting in Palo Alto (17 mi)

+208 other locations

Overseen byClaire M Mazewski

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Claire M Mazewski

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients with newly diagnosed brain tumors, specifically supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. They should have undergone recent surgery and meet specific health criteria like normal heart and lung function, adequate blood counts, and no prior chemo or radiation therapy.

Inclusion Criteria

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

My breathing and oxygen levels are stable.

My blood counts meet the required levels.

See 12 more

Treatment Details

Interventions

Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Carboplatin (Platinum-containing Compound)
Cisplatin (Platinum-containing Compound)
Cyclophosphamide (Alkylating agents)
Etoposide (Topoisomerase II inhibitors)
Filgrastim (Hematopoietic Growth Factors)
Leucovorin Calcium (Folic Acid Analog)
Methotrexate (Antimetabolites)
Thiotepa (Alkylating agents)
Vincristine Sulfate (Vinca alkaloids)

Trial OverviewThe study compares two chemotherapy regimens before intense chemotherapy followed by stem cell transplant to see which works better for treating these brain tumors. It includes drugs like Cisplatin, Methotrexate, Thiotepa, Carboplatin, Cyclophosphamide and others.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (induction+consolidation chemotherapy, autologous PBSC)Experimental Treatment12 Interventions

Patients receive vincristine IV over 1 minute on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or PO every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses. Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (induction+consolidation chemotherapy, autologous PBSC)Active Control10 Interventions

Patients receive vincristine IV over 1 minute on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses. Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Cisplatin is already approved in Canada, Japan for the following indications: