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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020150 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: O6-benzylguanine Drug: temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive O6-benzylguanine (O6-BG) IV over 1 hour followed 30 minutes later by oral temozolomide daily for 5 days. Treatment continues every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of O6-BG is followed by sequential dose escalation of temozolomide. Cohorts of 3-6 patients receive escalating doses of O6-BG and temozolomide until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and prior to courses 1, 3, 6, 8, and 12.
PROJECTED ACCRUAL: A total of 21-48 patients will be accrued for this study within 1-2 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Katherine Warren, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000067880, NCI-00-C-0105I, NCI-237 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020150 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood rhabdomyosarcoma childhood craniopharyngioma recurrent childhood brain tumor recurrent neuroblastoma recurrent childhood liver cancer recurrent Wilms tumor and other childhood kidney tumors childhood central nervous system germ cell tumor recurrent osteosarcoma unspecified childhood solid tumor, protocol specific childhood germ cell tumor recurrent childhood soft tissue sarcoma childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma |
childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma previously treated childhood rhabdomyosarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent childhood ependymoma childhood teratoma childhood malignant testicular germ cell tumor childhood extragonadal germ cell tumor childhood malignant ovarian germ cell tumor recurrent childhood malignant germ cell tumor |
Liver Diseases Neuroectodermal Tumors, Primitive Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Neoplasms, Connective and Soft Tissue Wilms' Tumor Osteogenic Sarcoma Neuroepithelioma Ovarian Cancer O(6)-benzylguanine Glioma Kidney Diseases Nervous System Neoplasms Rhabdomyosarcoma |
Endocrine Gland Neoplasms Digestive System Neoplasms Testicular Cancer Astrocytoma Genital Neoplasms, Female Endocrine System Diseases Testicular Neoplasms Temozolomide Ewing's Sarcoma Carcinoma Brain Neoplasms Neuroectodermal Tumors Malignant Mesenchymal Tumor Sarcoma Gastrointestinal Neoplasms |
Liver Diseases Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Neoplasms, Nerve Tissue Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Urologic Neoplasms Neuroblastoma Genital Diseases, Female Liver Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Site |
Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal O(6)-benzylguanine Kidney Diseases Alkylating Agents Nervous System Neoplasms Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases |