NCT00002594

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

Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell rescue. * Determine the acute and delayed toxic effects of this regimen in these patients. OUTLINE: 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. Patients are followed every 6 months through year 4 and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.

Conditions

• Brain Tumor
• Central Nervous System Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Sargramostim	Given IV
DRUG	cyclophosphamide	Given IV
DRUG	melphalan	Given IV
PROCEDURE	autologous bone marrow transplantation
PROCEDURE	bone marrow ablation with stem cell support
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1994-09-01
• Primary completion: 2003-09-01
• Completion: 2007-03-01
• First posted: 2003-01-27
• Last updated: 2014-07-24

Locations

118 sites across 6 countries: United States, Australia, Canada, Netherlands, Puerto Rico, Switzerland