A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas
OBJECTIVES:
- Determine the maximum tolerated dose of atrasentan in patients with progressive or
recurrent malignant glioma.
- Describe the pharmacokinetics of this drug in these patients.
- Assess preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral atrasentan once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1
patient experiences dose-limiting toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Progressive or recurrent after prior radiotherapy with or without chemotherapy
- Prior low-grade glioma that has progressed to high-grade after therapy allowed
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
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
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- Transaminases no greater than 4 times upper limit of normal
- Hepatitis A, B, and C negative
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiovascular:
- No New York Heart Association class II, III, or IV cardiac disease
Other:
- HIV negative
- Mini mental score at least 15
- No other malignancy within the past 5 years except curatively treated carcinoma in
situ or basal cell skin cancer
- No serious concurrent infection
- No other concurrent medical illness that would preclude study entry
- No alcoholism or drug addiction within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent anticancer immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No more than 1 prior chemotherapy regimen
- No prior or concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)
- No prior atrasentan
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent anticancer hormonal therapy
Radiotherapy:
- See Disease Characteristics
- At least 3 months since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery:
- No concurrent anticancer surgery
Other:
- Recovered from prior therapy
- No more than 1 prior treatment regimen
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Surasak Phuphanich, MD, FAAN
Investigator Role:
Study Chair
Investigator Affiliation:
Winship Cancer Institute of Emory University
Authority:
United States: Federal Government
Study ID:
CDR0000068668
NCT ID:
NCT00017264
Start Date:
June 2002
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult anaplastic astrocytoma
- adult anaplastic oligodendroglioma
- adult giant cell glioblastoma
- adult gliosarcoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
