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)

NCT00783393 | Completed Phase 2 DMC

• 2 other identifiers: P03745JPC02-351-21
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Astrocytoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Progression-free survival in Step 1

  6 months

• Overall survival in Step 1

  6 months

• Tumor response in Step 1

  6 months

• Neurological improvement in Step 1

  6 months

• Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2

  6 months

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Drug: Temozolomide

Interventions

Temozolomide DRUG

Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.

Also known as: Temodal, Temodar, SCH 052365

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Astrocytoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: May 27, 2003
• Primary Completion: June 17, 2005
• Study Completion: June 17, 2005
• Last Updated: May 15, 2017

Record last verified: 2017-05