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Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme


OBJECTIVES: I. Determine overall survival rate and duration of disease free progression in
patients with newly diagnosed supratentorial glioblastoma multiforme treated with
carboxyamidotriazole and radiotherapy. II. Evaluate the toxicities of this combination
regimen in this patient population. III. Determine the correlations between pharmacokinetic
parameters and toxicity and/or drug activity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive induction therapy consisting of
radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks
followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral
carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression
or unacceptable toxicity. Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Fertile patients must use effective contraception
during and for 2 months after the study

PRIOR CONCURRENT THERAPY: No prior therapy for the brain tumor except surgery No prior
antineoplastic agents, including carboxyamidotriazole At least 10 days since prior hepatic
enzyme inducing anticonvulsants

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tom Mikkelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Josephine Ford Cancer Center at Henry Ford Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NABTT-9904 CDR0000067378

NCT ID:

NCT00004146

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Henry Ford HospitalDetroit, Michigan  48202