Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Direct Therapeutics
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006656
First received: December 6, 2000
Last updated: February 6, 2009
Last verified: August 2003
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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 II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine in ethanol Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | June 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.
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 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)
Additional patients then receive treatment with DTI-015 at the recommended phase II dose.
Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven supratentorial malignant glioblastoma multiforme
- Clear evidence of disease progression by MRI
- Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
- Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
- No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
- No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
- No tumor extension into the ventricular system
- Tumor volume no greater than 33.4 cm3
- At least one prior radiotherapy
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/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
- BUN no greater than 30 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection
- Afebrile unless fever due to presence of tumor
- No other concurrent serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No prior intracranial brachytherapy
Surgery:
- Recovered from any prior surgery
Other:
- No prior anticoagulants
- No other concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006656
Locations
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9416 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| United States, New Jersey | |
| John F. Kennedy Medical Center | |
| Edison, New Jersey, United States, 08820 | |
| United States, Ohio | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Virginia | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0631 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Direct Therapeutics
Investigators
| Study Chair: | Gene David Resnick, MD | Millennix |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006656 History of Changes |
| Other Study ID Numbers: | CDR0000068207, DTI-9901, UCMC-00042402, NCI-V00-1623 |
| Study First Received: | December 6, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases 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