Clinical Trials Directory

Trials / Completed

CompletedNCT00005952

Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors. * Evaluate the toxicity of this treatment in these patients. * Determine the activity of this treatment in these patients. OUTLINE: This is a dose escalation study of temozolomide. Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for 1-3 years, then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALfilgrastim
DRUGtemozolomide
PROCEDUREperipheral blood stem cell transplantation

Timeline

Start date
2000-08-01
Primary completion
2005-11-01
Completion
2005-11-01
First posted
2003-01-27
Last updated
2013-06-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00005952. Inclusion in this directory is not an endorsement.