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Home > "A" Clinical Trials Conditions > Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma  Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
For Condition: adult anaplastic astrocytoma,recurrent adult brain tumor,adult anaplastic oligodendroglioma,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 recurrentmalignantglioma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SurasakPhuphanich, Study Chair, Winship Cancer Institute of Emory University
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Gene Barnett 216-444-1379
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Louis Nabors 205-934-1432
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Michael Carducci 410-614-3977
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Pamela New 210-617-5161
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Kelly 336-716-4049
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Jeffrey Olson 404-778-5770
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
Additional Information:
Study ID Numbers: CDR0000068668; JHOC-NABTT-2008,NABTT-2008
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017264
Other Recurrent Adult Brain Tumor Studies:
1. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
2. Fenretinide in Treating Patients With Recurrent Malignant Glioma
3. Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
4. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
5. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
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