A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma

Merck Sharp & Dohme LLC0 sites151 target enrollmentMarch 2, 2005

ConditionsGlioblastoma Astrocytoma

InterventionsTemozolomide Semustine

DrugsTemozolomide Semustine

Overview

Phase: Phase 3
Intervention: Temozolomide
Conditions: Glioblastoma
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 151
Primary Endpoint: Progression-free survival
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.

Registry

clinicaltrials.gov

Start Date

March 2, 2005

End Date

February 23, 2006

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.
•Evidence of tumor progression or recurrence.
•Age \>=18 years.
•Karnofsky performance status \>=60%.
•Absolute neutrophil count \>=1,500/mm\^3, platelet count \>=100,000/mm\^3, hemoglobin \>=8g/dL.
•Serum BUN and creatinine \<1.5 times upper normal limit of testing laboratory (ULN).
•Total bilirubin and direct bilirubin \<1.5 times ULN.
•SGOT, SGPT \<3 times ULN; alkaline phosphatase \<2 times ULN.
•Life expectancy greater than 3 months.
•Informed consent obtained.

Exclusion Criteria

•Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
•Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
•Vincristine within 2 weeks prior to study drug administration.
•Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
•Surgery within 3 weeks, inclusive, prior to study drug administration.
•Acute infection requiring intravenous antibiotics.
•Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
•Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
•Known HIV positive or AIDS-related illness.
•Pregnant or nursing women.