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Phase II Randomized Study of Adjuvant Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Patients Who Have Undergone Radiotherapy for Supratentorial Glioblastoma Multiforme
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
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
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Active | 18 and over | MDA-ID-02586
2004-0662, 6636, NCI-6636, MDA-2004-0662, NCT00112502 |
Objectives - 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.
- 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 Chemotherapy - Prior temozolomide in combination with radiotherapy allowed
- No other prior or concurrent chemotherapy
Endocrine therapy 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 Performance status Life expectancy 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 176A total of 176 patients (22 per treatment arm) will be accrued for this study. Outcomes Primary Outcome(s)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.
Trial Contact Information
Trial Lead Organizations University of Texas M.D. Anderson CCOP Research Base | | | | Mark Gilbert, MD, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| Arkansas |
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Fort Smith |
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| | | | | | | | | Hembree Mercy Cancer Center at St. Edward Mercy Medical Center |
| | | Tony Flippin, MD | | Ph: | 479-484-4700 | | 800-333-1305 |
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| | Email:
tflippin@cooperclinic.com |
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| Florida |
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Orlando |
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| | | | M.D. Anderson Cancer Center at Orlando |
| | | Jennifer Tseng, MD | | Ph: | 407-648-3800 ext. 8553 | | |
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| | Email:
jtseng@mdanderson.org |
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| Georgia |
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Atlanta |
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| | | | CCOP - Atlanta Regional |
| | | Thomas Seay, MD, PhD | |
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| Illinois |
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Decatur |
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| | | | CCOP - Central Illinois |
| | | James Wade, MD | |
| | Email:
jlwade3@sbcglobal.net |
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| Kansas |
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Wichita |
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| | | | CCOP - Wichita |
| | | Shaker Dakhil, MD, FACP | | Ph: | 316-268-5784 | | 800-362-5784 |
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| Michigan |
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Grand Rapids |
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| | | | CCOP - Grand Rapids |
| | | Marianne Lange, MD | |
| | Email:
marianne.lange@grcop.org |
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Kalamazoo |
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| | | CCOP - Kalamazoo |
| | | Raymond Lord, MD | |
| | Email:
rlord@wmcc.org |
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| Missouri |
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Kansas City |
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| | | | CCOP - Kansas City |
| | | Rakesh Gaur, MD | |
| | Email:
rgaur@saint-lukes.org |
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Springfield |
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| | | Cancer Research for the Ozarks |
| | | John Goodwin, MD | |
| | Email:
jgoodwin@sprg.mercy.net |
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| South Carolina |
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Spartanburg |
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| | | | CCOP - Upstate Carolina |
| | | James Bearden, MD | |
| | Email:
jbearde@srhs.com |
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| Texas |
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Houston |
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| | | | M. D. Anderson Cancer Center at University of Texas |
| | | Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas | |
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| 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 | | 2008-12-07 | | | NCI Grant/Contract Number | | CA45809, CA16672 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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