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A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Surasak Phuphanich, MD, FAAN

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Federal Government

Study ID:

CDR0000068668

NCT ID:

NCT00017264

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104