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

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Head and Neck Cancer; Kidney Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Testicular Germ Cell Tumor

• Registration Number: NCT00005952
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2000-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response at 12 months
Disease-free survival at 12 months

Secondary Outcome Measures

Name	Time	Method
Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States