Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00112502
First received: June 2, 2005
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Isotretinoin may help cells that are involved in the body's immune response to work better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which temozolomide-containing regimen is more effective in treating glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: Celecoxib Drug: Isotretinoin Drug: Temozolomide Drug: Thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Progression-free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of participants with no disease progression, measured at 6 months. A combination of the neurological examination and MRI brain scan used to define progression.
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I: TMZ
Oral Temozolomide (TMZ) 150 mg/m^2 once daily on days 1-7 and 15-21.
|
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
|
|
Experimental: Arm II: TMZ + Thalidomide
Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
|
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
Drug: Thalidomide
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Other Name: Thalomid
|
|
Experimental: Arm III: TMZ + Isotretinoin
Temozolomide as in Arm I and oral Isotretinoin 40 mg/m^2 twice daily on days 1-21.
|
Drug: Isotretinoin
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Other Names:
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
|
|
Experimental: Arm IV: TMZ + Celecoxib
Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28.
|
Drug: Celecoxib
400 mg orally twice a day continuous dosing
Other Name: Celebrex
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
|
|
Experimental: Arm V: TMZ + Thalidomide + Isotretinoin
Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III.
|
Drug: Isotretinoin
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Other Names:
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
Drug: Thalidomide
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Other Name: Thalomid
|
|
Experimental: Arm VI: TMZ + Thalidomide + Celecoxib
Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV.
|
Drug: Celecoxib
400 mg orally twice a day continuous dosing
Other Name: Celebrex
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
Drug: Thalidomide
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Other Name: Thalomid
|
|
Experimental: Arm VII: TMZ + Isotretinoin + Celecoxib
Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
|
Drug: Celecoxib
400 mg orally twice a day continuous dosing
Other Name: Celebrex
Drug: Isotretinoin
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Other Names:
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
|
|
Experimental: Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
|
Drug: Celecoxib
400 mg orally twice a day continuous dosing
Other Name: Celebrex
Drug: Isotretinoin
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Other Names:
Drug: Temozolomide
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Other Name: Temodar
Drug: Thalidomide
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Other Name: Thalomid
|
Detailed Description:
OBJECTIVES:
- Compare the efficacy of adjuvant temozolomide (TMZ) 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.
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.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Serum glutamate pyruvate transaminase (SGPT) < 2 times upper limit of normal (ULN)
- Alkaline phosphatase < 2 times ULN
- Bilirubin ≤ 1.5 mg/dL
Renal
- blood urea nitrogen (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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112502
Locations
| United States, Arkansas | |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | |
| Fort Smith, Arkansas, United States, 72913 | |
| United States, Florida | |
| M.D. Anderson Cancer Center at Orlando | |
| Orlando, Florida, United States, 32806-2134 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65804 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00112502 History of Changes |
| Other Study ID Numbers: | 2004-0662, MDA-ID-02586, NCI-6636, MDA-2004-0662, CDR0000432954 |
| Study First Received: | June 2, 2005 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Isotretinoin |
Tretinoin Temozolomide Thalidomide Dacarbazine Celecoxib Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013