Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

NCT00017264 | Completed Phase 1

• 3 other identifiers: CDR0000068668NABTT-2008JHOC-NABTT-2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

atrasentan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (10)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Related Publications (1)

• 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.

  PMID: 18477765 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Gliosarcoma

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Surasak Phuphanich, MD, FAAN

  Emory University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Last Updated: January 13, 2009

Record last verified: 2004-08

Locations

US (10)