Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

NCT ID: NCT00017264

Last Updated: 2009-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

atrasentan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Surasak Phuphanich, MD, FAAN

Role: STUDY_CHAIR

Emory University

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

References

Phuphanich S, Carson KA, Grossman SA, Lesser G, Olson J, Mikkelsen T, Desideri S, Fisher JD; New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. Phase I safety study of escalating doses of atrasentan in adults with recurrent malignant glioma. Neuro Oncol. 2008 Aug;10(4):617-23. doi: 10.1215/15228517-2008-013. Epub 2008 May 13.

Reference Type: RESULT

PMID: 18477765 (View on PubMed)

Other Identifiers

NABTT-2008

Identifier Type: -

Identifier Source: secondary_id

JHOC-NABTT-2008

Identifier Type: -

Identifier Source: secondary_id

CDR0000068668

Identifier Type: -

Identifier Source: org_study_id