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Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00009854
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Direct Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gene David Resnick, MD
Principal Investigator Affiliation Millennix
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Metastatic Cancer
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Address

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128

Massey Cancer Center, Richmond, Virginia

Status

Address

Massey Cancer Center

Richmond, Virginia, 23298-0631