Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors

Recruiting in Palo Alto (17 mi)

+117 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.

Research Team

Donald H. Mahoney, MD

Principal Investigator

Texas Children's Cancer Center

Eligibility Criteria

Inclusion Criteria

Diagnosis of recurrent medulloblastoma or CNS germ cell tumor Histologic review of the primary intracranial or spinal cord tumor required

Biopsy and reduction of tumor bulk prior to study encouraged but not required

No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy

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Treatment Details

Interventions

Autologous Bone Marrow Transplantation (Procedure)
Bone Marrow Ablation with Stem Cell Support (Procedure)
Cyclophosphamide (Alkylating agents)
Melphalan (Alkylating agents)
Peripheral Blood Stem Cell Transplantation (Procedure)
Sargramostim (Cytokine)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Ablative chemo followed by autologous bone marrow (ABM) rescueExperimental Treatment6 Interventions

Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover.

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