Phase 2
Completed N=178
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Source: ClinicalTrials.gov NCT00112502 ↗Enrolled (actual)
178
Serious AEs
49.7%
Results posted
Oct 2021
Primary outcomePrimary: Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms — 7.6; 8.7 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms |
7.6; 8.7 | — |
| PRIMARY Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms |
8.3; 7.4 | — |
| PRIMARY Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms |
6.6; 9.1 | — |
| SECONDARY Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy |
8.3; 8.2 | — |
| SECONDARY Median Progression-Free Survival (PFS) of Individual Arms |
10.5; 7.7; 13.4; 6.5; 11.6; 7.9 | — |
| SECONDARY Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms |
18.3; 17.4 | — |
| SECONDARY Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms |
20.2; 17.1 | — |
| SECONDARY Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms |
17.1; 19.9 | — |
| SECONDARY Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy |
17.0; 20.1 | — |
| SECONDARY Overall Survival of Individual Arms |
21.2; 17.4; 18.1; 11.7; 23.1; 20.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00112502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.