Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme - Full Text View

Sponsor:	Direct Therapeutics
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006656

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 II

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:

MedlinePlus related topics: Cancer

Drug Information available for: Ethanol Carmustine

U.S. FDA Resources

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

Study Start Date:

June 2000

Detailed Description:

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:

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

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 February 13, 2012