Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI NABTT-2008 JHOC-NABTT-2008, NCT00017264

Objectives

1. Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma.
2. Describe the pharmacokinetics of this drug in these patients.
3. Assess preliminary evidence of therapeutic activity of this drug in these patients.

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 35 patients will be accrued for this study.

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.

Phuphanich S, Carson KA, Grossman SA, et al.: Phase I safety study of escalating doses of atrasentan in adults with recurrent malignant glioma. Neuro Oncol 10 (4): 617-23, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Surasak Phuphanich, MD, Protocol chair		Ph: 404-778-2214; 888-946-7447 Email: s_phuphanich@emoryhealthcare.org

Registry Information
Official Title		A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults with Recurrent Malignant Gliomas
Trial Start Date		2002-06-14
Registered in ClinicalTrials.gov		NCT00017264
Date Submitted to PDQ		2001-04-12
Information Last Verified		2004-08-11
NCI Grant/Contract Number		CA006973, CA062475

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