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Sponsored by: |
Direct Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00009854 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carmustine in ethanol Procedure: conventional surgery |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive neoadjuvant carmustine in ethanol (DTI-015) intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 3 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4, 8, and 12 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI
Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug
No tumors in the following locations of the brain:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
UCSF Cancer Center and Cancer Research Institute | |
San Francisco, California, United States, 94143-0128 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0631 |
Study Chair: | Gene David Resnick, MD | Millennix |
Study ID Numbers: | CDR0000068416, DTI-0002, UCSF-H7858-17520-01, NCI-V00-1642 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00009854 |
Health Authority: | United States: Federal Government |
adult glioblastoma adult tumors metastatic to brain adult anaplastic astrocytoma adult anaplastic ependymoma |
adult anaplastic oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Carmustine Central Nervous System Neoplasms Ependymoma Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasm Metastasis Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Ethanol Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |