Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme

Basic Trial Information

Objectives

1. Compare the efficacy of adjuvant temozolomide alone or in combination with thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free survival, in patients who have undergone radiotherapy for supratentorial glioblastoma multiforme.
2. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed supratentorial glioblastoma multiforme

• Must have undergone a biopsy OR subtotal or gross total resection of the tumor

• Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
  • No progressive disease after radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Prior temozolomide in combination with radiotherapy allowed
• No other prior or concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• See Chemotherapy

Surgery

• See Disease Characteristics
• No concurrent surgery

Other

• No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib)
• No other concurrent investigational drugs
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• SGPT < 2 times upper limit of normal (ULN)
• Alkaline phosphatase < 2 times ULN
• Bilirubin ≤ 1.5 mg/dL

Renal

• BUN ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN

Immunologic

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides
• No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
• No active infection

Gastrointestinal

• No inflammatory bowel disease
• No history of peptic ulcer disease
• No gastrointestinal bleeding within past 3 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception during and for 2 months after study participation
  • Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy
  • Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy
• No blood donation (for patients randomized to receive thalidomide)
• No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago
• No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease)
• No other serious medical illness

Expected Enrollment

A total of 180 patients will be accrued for this study.

Outcomes

Progression-free survival at 6 months
Toxicity

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 8 treatment arms.

• Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21.

• Arm II: Patients receive temozolomide as in arm I and oral thalidomide once daily on days 1-28.

• Arm III: Patients receive temozolomide as in arm I and oral isotretinoin twice daily on days 1-21.

• Arm IV: Patients receive temozolomide as in arm I and oral celecoxib twice daily on days 1-28.

• Arm V: Patients receive temozolomide as in arm I, thalidomide as in arm II, and isotretinoin as in arm III.

• Arm VI: Patients receive temozolomide as in arm I, thalidomide as in arm II, and celecoxib as in arm IV.

• Arm VII: Patients receive temozolomide as in arm I, isotretinoin as in arm III, and celecoxib as in arm IV.

• Arm VIII: Patients receive temozolomide as in arm I, thalidomide as in arm II, isotretinoin as in arm III, and celecoxib as in arm IV.

In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patient may receive additional courses of therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed for at least 30 days and then every 3 months thereafter.

Gilbert MR, Gonzalez J, Hunter K, et al.: A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. Neuro Oncol 12 (11): 1167-72, 2010.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

Mark Gilbert, MD, Protocol chair		Ph: 713-792-4008; 800-392-1611 Email: mrgilbert@mdanderson.org

Registry Information
Official Title		A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination with Possible Permutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Trial Start Date		2005-09-07
Trial Completion Date		2011-09-07 (estimated)
Registered in ClinicalTrials.gov		NCT00112502
Date Submitted to PDQ		2005-04-28
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA45809, CA16672

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