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| Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005952 |
Purpose
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.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Head and Neck Cancer Kidney Cancer Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Drug: filgrastim Drug: temozolomide Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Kidney Cancer Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma Wilms' Tumor |
| Drug Information available for: | Filgrastim Temozolomide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2000 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-CNS tumor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, North Carolina | |||||
| Duke Comprehensive Cancer Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| Duke University |
| National Cancer Institute (NCI) |
| Study Chair: | Henry S. Friedman, MD | Duke University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000067932, DUMC-1735-04-9R5, DUMC-1735-02-9R3, DUMC-1735-01-9R2, DUMC-1833-99-10, NCI-G00-1796 |
| First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005952 |
| Health Authority: | United States: Federal Government |
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