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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335075
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Astrocytoma Drug: Temozolomide Drug: Semustine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2, 2005
Actual Primary Completion Date : February 23, 2006
Actual Study Completion Date : February 23, 2006

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:
  • Temodal
  • Temodar
  • 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 Name: Methyl-CCNU

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 months, 3 months, and 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]
  2. Objective response [ Time Frame: 6 months ]
  3. Scoring of health-related quality of life [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Data/Documents: CSR Synopsis  This link exits the site

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00335075    
Other Study ID Numbers: P03644
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents