Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glioblastoma, Astrocytoma

Intervention / Treatment
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* Drug: Temozolomide
* Drug: Semustine


Participation Criteria
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Eligibility Criteria
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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. If palliative radiation is needed, agree to give it prior to initiating chemotherapy with study drug. If palliative radiation is required during treatment with study drug, the patient should be permanently discontinued from further treatment with study drug. Women of childbearing potential must use a medically accepted, effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug. 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. Men who are not advised to use an effective method of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temodal group<br>Subjects treated with temozolomide. | Drug: Temozolomide<br>* Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.<br>* Other names: SCH 052365;|
| Active Comparator: Semustine group<br>Subjects treated with semustine. | Drug: Semustine<br>* Semustine orally once every 28 days at a dose of 150 mg/m2/day.<br>* Other names: Methyl-CCNU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 months, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 months | 
| Objective response |  | 6 months | 
| Scoring of health-related quality of life |  | 6 months |