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The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

Study Purpose

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m^2).

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 19 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult patients, greater than 18 years old.
  • - Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).
  • - Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide, with radiological evidence of progression.
  • - GBM treated with concurrent chemoradiation with temozolomide according to the EORTC/NCIC (European Organization for Research & Treatment of Cancer/National Cancer Institute of Canada) protocol.
  • - Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]).
  • - Patients must be enrolled within 2 weeks of last radiological confirmation of progression, except for patients undergoing surgical resection.
  • - Patients undergoing surgical resection for recurrent disease must be enrolled within 2 weeks of the post-surgical scan.
  • - Patients with no residual disease after surgery are allowed.
  • - Steroids dose should have been stabilized during the last 2 weeks prior to enrollment.
  • - Use of medically approved contraception in fertile males and females.
  • - Women of childbearing potential must have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG [beta human chorionic gonadotropin]) within 24 hours of inclusion in the study.
  • - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • - Signed informed consent form.

Exclusion Criteria:

  • - GBM progression during the first 2 months of adjuvant temozolomide (5/28).
  • - AA progression during the first 2 months of standard temozolomide therapy (5/28).
  • - Chemotherapy for the malignant glioma other than temozolomide.
  • - More than one prior course of chemotherapy with temozolomide.
  • - Patient evolving from anaplastic glioma to GBM following primary therapy.
  • - Patient older than 70 years or who received no conventional chemoradiation regimen.
  • - Patient who received radiotherapy for recurrent disease.
  • - Patient with metastatic disease.
  • - Known human immunodeficiency virus (HIV) infection.
  • - History of non-compliance to other therapies.
  • - Inadequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion): - Absolute neutrophil count <=1.5 ×10^9/L; - Platelets <=100 ×10^9/L; - Hemoglobin <90 g/L; - Serum creatinine >=1.5 times upper limit of laboratory normal (ULN); - Total serum bilirubin >=1.5 times ULN; - ASAT (AST [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >2.0 times ULN; - Alkaline phosphatase of >2.5 times ULN.
  • - Known chronic hepatitis B or hepatitis C infection.
  • - Any other serious medical condition, according to the medical judgment of the physician prior to inclusion in the study.
  • - Any medical condition that could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
  • - Other malignancies during the previous 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.
  • - Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before inclusion in the study.

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.

 NCT00392171
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 2
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.

 Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma
Arms & Interventions

Arms

Experimental: Temozolomide

Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.

Interventions

Drug: - Temozolomide

Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression

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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