Clinical trial NCT00783393: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Astrocytoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall response in Step 1
timeFrame: 6 months
measure: Incidence rate and severity of adverse events with administration of temozolomide in Step 1
timeFrame: 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
Secondary outcomes:
measure: Progression-free survival in Step 1
timeFrame: 6 months
measure: Overall survival in Step 1
timeFrame: 6 months
measure: Tumor response in Step 1
timeFrame: 6 months
measure: Neurological improvement in Step 1
timeFrame: 6 months
measure: Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2
timeFrame: 6 months
measure: Progression-free survival in Step 2
timeFrame: Up to 2 years
measure: Overall survival in Step 2
timeFrame: Up to 2 years
measure: Overall response in Step 2
timeFrame: Up to 2 years
measure: Effect on neurological symptoms in Step 2
timeFrame: Up to 2 years
measure: Safety in Step 2
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
References: