Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
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.
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.
;
Primary Purpose: Treatment
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