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Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)

Study Purpose

The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.

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 - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Only the patients who meet all these criteria can be enrolled in the study:
  • - Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
  • - Gross total resection or partial resection (imaging) >70%.
  • - At least be capable to obtain a tissue sample for MGMT analysis during surgery.
  • - Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
  • - Age >=18 and <=70 years.
  • - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • - Life expectancy >=9 months.
  • - Laboratory test values must satisfy the following criteria: - absolute neutrophil count >=1.5 x 10^9/L; - platelet count >=100 x 10^9/L; - hemoglobin >=80 g/L; - blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN); - total bilirubin and direct bilirubin < 1.5 x ULN; - alanine aminotransferase and aspartate aminotransferase < 3 x ULN; - alkaline phosphatase < 2 x ULN.
  • - Patients must be willing to provide written informed consent.
  • - Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.

Exclusion Criteria:

Patients will not be enrolled if any of the following criteria apply:
  • - Patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years.
  • - Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery.
  • - Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).
  • - Patient with metastatic lesions at the subtentorial or outside of calvaria.
  • - Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.
  • - Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping.
  • - Patient with acute infections requiring intravenous antibiotics.
  • - Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
  • - Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (AIDS)-related illness.
  • - Woman who is pregnant or breastfeeding.
  • - Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents.
  • - Patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.

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.

 NCT00686725
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 4
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
Arms & Interventions

Arms

Active Comparator: Temozolomide + Radiation

Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.

Experimental: Temozolomide alone, then Temozolomide + Radiation

Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.

Interventions

Drug: - Temozolomide

Radiation: - Radiotherapy

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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