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)

• Status: Completed
• Trial end date: 2005-06-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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.

• 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.

• Age >=18 years, either sex, inpatients or outpatients.

• Use of medically approved contraception methods in fertile subjects.

• Karnofsky performance status >=70.

• Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.

• 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.

• Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.

• 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.

• Life expectancy >=12 weeks.

• Written informed consent obtained.

Exclusion Criteria:

• 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.