Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

May 12, 2017 updated by: Merck Sharp & Dohme LLC

A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma

The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.
  • Evidence of tumor progression or recurrence.
  • Age >=18 years.
  • Karnofsky performance status >=60%.
  • Absolute neutrophil count >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin >=8g/dL.
  • Serum BUN and creatinine <1.5 times upper normal limit of testing laboratory (ULN).
  • Total bilirubin and direct bilirubin <1.5 times ULN.
  • SGOT, SGPT <3 times ULN; alkaline phosphatase <2 times ULN.
  • Life expectancy greater than 3 months.
  • Informed consent obtained.
  • If palliative radiation is needed, agree to give it prior to initiating chemotherapy with study drug. If palliative radiation is required during treatment with study drug, the patient should be permanently discontinued from further treatment with study drug.
  • Women of childbearing potential must use a medically accepted, effective method of contraception.
  • Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug.

Exclusion Criteria:

  • Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
  • Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
  • Vincristine within 2 weeks prior to study drug administration.
  • Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
  • Surgery within 3 weeks, inclusive, prior to study drug administration.
  • Acute infection requiring intravenous antibiotics.
  • Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
  • Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
  • Known HIV positive or AIDS-related illness.
  • Pregnant or nursing women.
  • Men who are not advised to use an effective method of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temodal group
Subjects treated with temozolomide.
Drug: Temozolomide
Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
Other Names:
  • Temodar
  • Temodal
  • SCH 052365
Active Comparator: Semustine group
Subjects treated with semustine.
Drug: Semustine
Semustine orally once every 28 days at a dose of 150 mg/m2/day.
Other Names:
  • Methyl-CCNU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 months, 3 months, and 6 months
2 months, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months
6 months
Objective response
Time Frame: 6 months
6 months
Scoring of health-related quality of life
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2005

Primary Completion (Actual)

February 23, 2006

Study Completion (Actual)

February 23, 2006

Study Registration Dates

First Submitted

June 6, 2006

First Submitted That Met QC Criteria

June 6, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03644

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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