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| Sponsor: | Pediatric Brain Tumor Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00006246 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this treatment regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Leukemia Lymphoma Metastatic Cancer Retinoblastoma Sarcoma |
Drug: busulfan |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis |
| Enrollment: | 28 |
| Study Start Date: | November 2000 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks. Patients with complete or partial response or stable disease may continue therapy once a week for 2 weeks, once a week every other week for 2 treatments, and then once a month thereafter in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for the first year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38 months.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CNS malignancy, including any of the following:
Recurrent or persistent leptomeningeal leukemia, lymphoma, or germ cell tumor refractory to conventional therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Concurrent systemic chemotherapy allowed for recurrent disease after first course of treatment except for the following:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Study Chair: | Sri Gururangan, MD | Duke University |
More Information
| Responsible Party: | Pediatric Brain Tumor Consortium ( James M. Boyett/PBTC Operations and Biostatistics Center Executive Director ) |
| Study ID Numbers: | CDR0000068178, PBTC-004 |
| Study First Received: | September 11, 2000 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006246 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent childhood acute lymphoblastic leukemia childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma recurrent childhood brain tumor recurrent retinoblastoma recurrent childhood lymphoblastic lymphoma childhood central nervous system germ cell tumor recurrent childhood acute myeloid leukemia recurrent/refractory childhood Hodgkin lymphoma leptomeningeal metastases childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor |
childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma recurrent childhood large cell lymphoma recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma recurrent childhood malignant germ cell tumor |
|
Retinal Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Retinoblastoma Neoplasms, Connective and Soft Tissue Leukemia Neoplastic Processes Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Neoplasm Metastasis Alkylating Agents Lymphoma Retinal Diseases Nervous System Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Eye Neoplasms Eye Diseases Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neuroectodermal Tumors |