SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)
- Registration Number
- NCT00783393
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:
- unequivocal evidence of tumor recurrence or aggravation by MRI scan after treatment for initial onset; the lesions must be measurable;
- anaplastic astrocytoma diagnosed histologically by the last pathological diagnostic tests (including initial diagnosis) prior to initial administration of temozolomide;
- tissue samples available for Central Pathologic Reviewer;
- pathologic diagnosis report by the study-conducting medical institution must be available for the sponsor.
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MRI-related criteria:
- MRI scan performed within 14 days before initial temozolomide administration;
- assessable tumor site confirmed by MRI;
- dosage of steroidal agents not increased within 7 days before MRI prior to initial temozolomide administration, except for postoperative subjects for first relapse;
- MRI performed at the Principal Investigator's study location or designated radiology facility during the study.
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Age >=18 years, either sex, inpatients or outpatients.
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Use of medically approved contraception methods in fertile subjects.
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Karnofsky performance status >=70.
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Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.
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Criteria regarding treatment of initial onset:
- tumor biopsy, regardless of tumor resection at initial diagnosis;
- prior radiation therapy;
- prior chemotherapy with up to one nitrosourea-containing regimen.
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Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.
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For subjects who had surgical resection of tumor at first relapse:
- MRI scan must have been performed within 72 hours after surgery.
- the dose of steroidal agents must be reduced before temozolomide administration.
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Life expectancy >=12 weeks.
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Written informed consent obtained.
- History of treatment with dacarbazine.
- Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.
- Subjects who received interstitial radiotherapy or stereotactic radiosurgery.
- Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.
- Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.
- Subjects not recovered from acute toxicity due to previous therapy.
- High-risk subjects with complication of diseases other than malignant tumor, or who require systemic administration of antibiotics for infection.
- Previous or concurrent malignancies at other sites.
- Pregnant or nursing women.
- Women of childbearing potential not using an effective method of contraception.
- Subjects previously treated with temozolomide.
- Participation in an ongoing clinical study, or in other clinical studies within 6 months before initial temozolomide administration.
- Subjects found inappropriate for the study by the investigator or subinvestigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Temozolomide The study consists of two steps: * Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and * Step 2, the long-term treatment phase, where subjects with at least disease stabilization at the end of Step 1 may continue temozolomide treatment until unacceptable toxicity or disease progression occur, up to a maximum of 2 years from the start of treatment in Cycle 1.
- Primary Outcome Measures
Name Time Method Overall response in Step 1 6 months Incidence rate and severity of adverse events with administration of temozolomide in Step 1 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
- Secondary Outcome Measures
Name Time Method Neurological improvement in Step 1 6 months Overall survival in Step 2 Up to 2 years Effect on neurological symptoms in Step 2 Up to 2 years Progression-free survival in Step 1 6 months Overall survival in Step 1 6 months Tumor response in Step 1 6 months Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2 6 months Overall response in Step 2 Up to 2 years Progression-free survival in Step 2 Up to 2 years Safety in Step 2 Up to 2 years