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Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm Clinical research trials and Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm clinical trial. Human subjects often receive the most effective healthcare possible for their Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm  Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
For Condition: brain metastases,adult anaplastic oligodendroglioma,adult glioblastoma multiforme,adult malignant ependymoma,adult anaplastic astrocytoma
Status: No longer recruiting
Sponsor(s): Direct Therapeutics ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeneResnick, Study Chair, Millennix
Massey Cancer Center
Richmond, Virginia, 23298-0631
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Additional Information:
Study ID Numbers: CDR0000068416; NCI-V00-1642,UCSF-H7858-17520-01,DTI-0002
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009854
Other Adult Malignant Ependymoma Studies:
1. Karenitecin in Treating Patients With Recurrent Malignant Glioma
2. Brachytherapy in Treating Patients With Recurrent Malignant Glioma
3. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
4. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
5. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other adult malignant ependymoma Clinical Trials
Other Virginia Clinical Trials
Other Richmond Clinical Trials
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
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