Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00783393
Start Date
May 27 2003
End Date
June 17 2005
Last Update
May 15 2017
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