Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: atrasentan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas |
| Study Start Date: | June 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center at University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Study Chair: | Surasak Phuphanich, MD, FAAN | Winship Cancer Institute of Emory University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00017264 History of Changes |
| Other Study ID Numbers: | CDR0000068668, NABTT-2008, JHOC-NABTT-2008 |
| Study First Received: | June 6, 2001 |
| Last Updated: | January 10, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma |
adult anaplastic oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases |
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on June 17, 2013