A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
18 Years
75 Years
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
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.)
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gene David Resnick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Millennix
Authority:
United States: Federal Government
Study ID:
CDR0000068207
NCT ID:
NCT00006656
Start Date:
June 2000
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| John F. Kennedy Medical Center | Edison, New Jersey 08818 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Evanston Northwestern Health Care | Evanston, Illinois 60201 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
