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

Primary Purpose

Brain and Central Nervous System Tumors, Metastatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carmustine in ethanol
conventional surgery
Sponsored by
Direct Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, tumors metastatic to brain, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Cancer Center and Cancer Research Institute
  • Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
November 5, 2013
Sponsor
Direct Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00009854
Brief Title
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
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 Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Direct Therapeutics

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Metastatic Cancer
Keywords
adult glioblastoma, tumors metastatic to brain, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine in ethanol
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene David Resnick, MD
Organizational Affiliation
Millennix
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0631
Country
United States

12. IPD Sharing Statement

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

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