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)

Conditions: Astrocytoma

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.


Eligibility 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.