NCT00002594|CompletedPhase 2DMC

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

Children's Oncology Group ClinicalTrials.gov

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4 other identifiers

9430COG-P9430POG-9430CDR0000063784

Study Type

interventional

Target

Locations

6 countries

Sites

118

Timeline

RegisteredJan 2003

StartedSep 1994

CompletionMar 2007

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Sep 1994

Longer than P75 for phase_2

Geographic Reach

6 countries

118 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.5 years study duration

Study Start

First participant enrolled

September 1, 1994

Completed

5.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed

Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

9 years

First QC Date

November 1, 1999

Last Update Submit

July 23, 2014

Conditions

Brain Tumor Central Nervous System Tumor

Keywords

recurrent childhood brain tumorchildhood central nervous system germ cell tumorrecurrent childhood medulloblastoma

Outcome Measures

Primary Outcomes (1)

Progression-free survival
1-2 years

Study Arms (1)

Ablative chemo followed by autologous bone marrow (ABM) rescue

EXPERIMENTAL

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.

Biological: SargramostimDrug: cyclophosphamideDrug: melphalanProcedure: autologous bone marrow transplantationProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantation

Interventions

SargramostimBIOLOGICAL

Given IV

Also known as: M-CSF, GM-CSF, Granulocyte macrophage-colony stimulating factor, Prokine, Leukine, NSC #6137