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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00335075
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Astrocytoma
Arms & Interventions

Arms

Experimental: Temodal group

Subjects treated with temozolomide.

Active Comparator: Semustine group

Subjects treated with semustine.

Interventions

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.

Drug: - Semustine

Semustine orally once every 28 days at a dose of 150 mg/m2/day.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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