Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
This study is ongoing, but not recruiting participants.
Sponsored by: Direct Therapeutics
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009854
  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
Drug: carmustine in ethanol
Procedure: conventional surgery
Phase I
Phase II

MedlinePlus related topics: Brain Cancer Cancer
Drug Information available for: Carmustine Ethanol
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009854

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
Sponsors and Collaborators
Direct Therapeutics
Investigators
Study Chair: Gene David Resnick, MD Millennix
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult tumors metastatic to brain
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009