Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Recruitment status was Active, not recruiting
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Purpose
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 Metastatic Cancer |
Drug: carmustine in ethanol Procedure: conventional surgery |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol (DTI-015) followed by tumor resection.
- Determine the qualitative and quantitative toxicity of this treatment regimen in these patients.
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.
Eligibility| 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
- Glioblastoma multiforme
- Anaplastic ependymoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma OR
- Metastatic tumor to the brain other than melanoma
- Planned resection of tumor (must be first surgery for recurrent disease)
- Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3
Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug
- Tumor is spherical, spheroid, or ovoid
- No tumors shaped into 3 or more components (e.g., multicentric or multilobulated)
- No tumors extending into the ventricular system
- Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)
- Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present
No tumors in the following locations of the brain:
- Brainstem (pons or medulla)
- Midbrain (mesencephalon)
- Primary sensorimotor cortex in the dominant hemisphere
- Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No evidence of bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 2.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 40 mL/min OR
- BUN no greater than 30 mg/dL
Other:
- No active uncontrolled infection
- Afebrile (37.5 degrees C) unless fever due to tumor
- No other unstable or severe medical condition
- No complicating medical or psychiatric problem that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered
- No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No prior intracranial brachytherapy
- No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI
Surgery:
- See Disease Characteristics
- Prior surgery allowed
- No anti-tumor surgery within 12 weeks after study drug
Other:
- No concurrent anticoagulants
- No other concurrent investigational agents
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00009854 History of Changes |
| Other Study ID Numbers: | CDR0000068416, DTI-0002, UCSF-H7858-17520-01, NCI-V00-1642 |
| Study First Received: | February 2, 2001 |
| Last Updated: | August 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma tumors metastatic to brain adult anaplastic astrocytoma adult anaplastic ependymoma |
adult anaplastic oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplastic Processes Pathologic Processes Neoplasms by Site Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013