A Phase 2 interventional study of Celecoxib and Isotretinoin in Brain and Central Nervous System Tumors and Glioblastoma Multiforme, sponsored by M.D. Anderson Cancer Center. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-18.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 8 treatment arms.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 178 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Gastrointestinal
Other
Fertile patients must use effective double-method contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Oral Temozolomide (TMZ) 150 mg/m\^2 once daily on days 1-7 and 15-21.
Drug: Temozolomide
Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
Drug: Temozolomide · Drug: Thalidomide
Temozolomide as in Arm I and oral Isotretinoin 40 mg/m\^2 twice daily on days 1-21.
Drug: Isotretinoin · Drug: Temozolomide
Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28.
Drug: Celecoxib · Drug: Temozolomide
Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III.
Drug: Isotretinoin · Drug: Temozolomide · Drug: Thalidomide
Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV.
Drug: Celecoxib · Drug: Temozolomide · Drug: Thalidomide
Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Drug: Celecoxib · Drug: Isotretinoin · Drug: Temozolomide
Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Drug: Celecoxib · Drug: Isotretinoin · Drug: Temozolomide · Drug: Thalidomide
400 mg orally twice a day continuous dosing
Also known as: Celebrex
40 mg/m\^2 orally twice a day (total daily dose = 80 mg/m\^2) days 1-21 of a 28 day cycle.
Also known as: Accutane, 13-Cis-Retinoic Acid
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Also known as: Temodar
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)
Also known as: Thalomid
Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up, up to one year (12 study cycles).
Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Progression-Free Survival (PFS) of Individual Arms
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 3 months from randomization until progression of disease, death or last follow-up.
Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 3 months from randomization until progression of disease, death or last follow-up.
Overall Survival of Individual Arms
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: Every 3 months from randomization until progression of disease, death or last follow-up.
Recruitment Period: September 2005 to February 2011 from various hospitals and institutions representing the Community Clinical Oncology Program (CCOP). A total of 146 participants were accrued at MD Anderson Cancer Center and 32 at the remaining participating sites.
| Milestone | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib |
|---|---|---|---|---|---|---|---|---|
| Started | 22 | 22 | 22 | 22 | 23 | 22 | 23 | 22 |
| Completed | 22 | 21 | 21 | 18 | 21 | 17 | 20 | 15 |
| Not completed | 0 | 1 | 1 | 4 | 2 | 5 | 3 | 7 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 4 | 2 | 5 | 3 | 7 |
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII | No Thalidomide: Arm I, Arm III, Arm IV and Arm V |
|---|---|---|
| Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms | 7.6 (NA to NA) | 8.7 (NA to NA) |
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Celecoxib: Arm III, Arm V, Arm VI and Arm VIII | No Celecoxib: Arm I, Arm II, Arm IV and Arm VII |
|---|---|---|
| Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms | 8.3 (NA to NA) | 7.4 (NA to NA) |
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII | No Isotretinoin: Arm I, Arm II, Arm III and Arm VI |
|---|---|---|
| Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms | 6.6 (NA to NA) | 9.1 (NA to NA) |
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Doublet (2 Agents): Arm II, Arm III and Arm IV | Triplet (3 Agents): Arm V, Arm VI and Arm VII |
|---|---|---|
| Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy | 8.3 (NA to NA) | 8.2 (NA to NA) |
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib |
|---|---|---|---|---|---|---|---|---|
| Median Progression-Free Survival (PFS) of Individual Arms | 10.5 (NA to NA) | 7.7 (NA to NA) | 13.4 (NA to NA) | 6.5 (NA to NA) | 11.6 (NA to NA) | 7.9 (NA to NA) | 6.2 (NA to NA) | 5.8 (NA to NA) |
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII | No Thalidomide: Arm I, Arm III, Arm IV and Arm V |
|---|---|---|
| Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms | 18.3 (NA to NA) | 17.4 (NA to NA) |
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Celecoxib: Arm III, Arm V, Arm VI and Arm VIII | No Celecoxib: Arm I, Arm II, Arm IV and Arm VII |
|---|---|---|
| Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms | 20.2 (NA to NA) | 17.1 (NA to NA) |
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII | No Isotretinoin: Arm I, Arm II, Arm III and ARM VI |
|---|---|---|
| Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms | 17.1 (NA to NA) | 19.9 (NA to NA) |
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Doublet (2 Agents): Arm II, Arm III and Arm IV | Triplet (3 Agents): Arm V, Arm VI and Arm VII |
|---|---|---|
| Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy | 17.0 (NA to NA) | 20.1 (NA to NA) |
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| months | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib |
|---|---|---|---|---|---|---|---|---|
| Overall Survival of Individual Arms | 21.2 (NA to NA) | 17.4 (NA to NA) | 18.1 (NA to NA) | 11.7 (NA to NA) | 23.1 (NA to NA) | 20.2 (NA to NA) | 17.9 (NA to NA) | 18.5 (NA to NA) |
Collected over Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from study drug administration to time of progression, death, or last follow-up,1 year", "Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from study drug administration to time of progression, death, or last follow-up, up to 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I: TMZ | — | 11/22 (50%) | 22/22 (100%) |
| Arm II: TMZ + Thalidomide | — | 9/21 (42.9%) | 21/21 (100%) |
| Arm III: TMZ + Celecoxib | — | 7/21 (33.3%) | 21/21 (100%) |
| Arm IV: TMZ + Isotretinoin | — | 8/18 (44.4%) | 18/18 (100%) |
| Arm V: TMZ + Isotretinoin + Celecoxib | — | 12/21 (57.1%) | 21/21 (100%) |
| Arm VI: TMZ + Thalidomide + Celecoxib | — | 15/17 (88.2%) | 17/17 (100%) |
| Arm VII: TMZ + Thalidomide + Isotretinoin | — | 8/20 (40%) | 20/20 (100%) |
| Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | — | 7/15 (46.7%) | 15/15 (100%) |
| Event | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib |
|---|---|---|---|---|---|---|---|---|
| LymphopeniaBlood and lymphatic system disorders | 10/22 | 5/21 | 5/21 | 5/18 | 11/21 | 10/17 | 3/20 | 4/15 |
| NeutrophilsBlood and lymphatic system disorders | 0/22 | 3/21 | 0/21 | 2/18 | 0/21 | 2/17 | 3/20 | 1/15 |
| PlateletsBlood and lymphatic system disorders | 1/22 | 1/21 | 1/21 | 1/18 | 0/21 | 2/17 | 1/20 | 0/15 |
| LeukocytesBlood and lymphatic system disorders | 0/22 | 2/21 | 0/21 | 2/18 | 0/21 | 1/17 | 2/20 | 0/15 |
| ThrombosisVascular disorders | 1/22 | 0/21 | 0/21 | 1/18 | 0/21 | 1/17 | 2/20 | 1/15 |
| ObesityGeneral disorders | 0/22 | 0/21 | 0/21 | 0/18 | 1/21 | 0/17 | 0/20 | 1/15 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/22 | 0/21 | 0/21 | 0/18 | 0/21 | 0/17 | 1/20 | 1/15 |
| Erythema MultiformeSkin and subcutaneous tissue disorders | 0/22 | 0/21 | 0/21 | 0/18 | 0/21 | 0/17 | 0/20 | 1/15 |
| DeathGeneral disorders | 0/22 | 1/21 | 0/21 | 0/18 | 0/21 | 1/17 | 1/20 | 0/15 |
| Sinus BradycardiaCardiac disorders | 0/22 | 0/21 | 0/21 | 0/18 | 0/21 | 1/17 | 0/20 | 0/15 |
| Event | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib |
|---|---|---|---|---|---|---|---|---|
| LeukocytesBlood and lymphatic system disorders | 16/22 | 14/21 | 16/21 | 15/18 | 16/21 | 17/17 | 11/20 | 14/15 |
| LymphopeniaBlood and lymphatic system disorders | 22/22 | 21/21 | 21/21 | 18/18 | 21/21 | 17/17 | 12/20 | 12/15 |
| NeutrophilsBlood and lymphatic system disorders | 13/22 | 11/21 | 9/21 | 10/18 | 11/21 | 17/17 | 7/20 | 12/15 |
| FatigueGeneral disorders | 19/22 | 13/21 | 16/21 | 14/18 | 17/21 | 17/17 | 14/20 | 14/15 |
| HemoglobinBlood and lymphatic system disorders | 16/22 | 8/21 | 17/21 | 14/18 | 15/21 | 17/17 | 9/20 | 11/15 |
| Dry SkinSkin and subcutaneous tissue disorders | 3/22 | 2/21 | 4/21 | 11/18 | 19/21 | 9/17 | 9/20 | 10/15 |
| PlateletsBlood and lymphatic system disorders | 13/22 | 5/21 | 12/21 | 13/18 | 11/21 | 14/17 | 9/20 | 11/15 |
| HyperglycemiaMetabolism and nutrition disorders | 18/22 | 8/21 | 17/21 | 10/18 | 11/21 | 9/17 | 10/20 | 9/15 |
| HeadacheNervous system disorders | 10/22 | 9/21 | 9/21 | 14/18 | 12/21 | 8/17 | 13/20 | 8/15 |
| HypertriglyceridemiaMetabolism and nutrition disorders | 6/22 | 7/21 | 7/21 | 10/18 | 16/21 | 3/17 | 11/20 | 11/15 |
A 178 participants in total were randomized, out of which 23 participants were randomized but not treated because of consent withdrawal with some further difficulties obtaining insurance coverage.
| Age, Customized(participants) | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=19 years: | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Between 20 and 59 years: | 17 | 12 | 17 | 14 | 20 | 18 | 15 | 17 | 130 |
| >=60 years: | 5 | 10 | 5 | 7 | 3 | 4 | 8 | 5 | 47 |
| Sex: Female, Male(Participants) | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 7 | 10 | 5 | 8 | 4 | 6 | 6 | 9 | 55 |
| Male | 15 | 12 | 17 | 14 | 19 | 16 | 17 | 13 | 123 |
| Region of Enrollment(participants) | Arm I: TMZ | Arm II: TMZ + Thalidomide | Arm III: TMZ + Celecoxib | Arm IV: TMZ + Isotretinoin | Arm V: TMZ + Isotretinoin + Celecoxib | Arm VI: TMZ + Thalidomide + Celecoxib | Arm VII: TMZ + Thalidomide + Isotretinoin | Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 22 | 22 | 22 | 22 | 23 | 22 | 23 | 22 | 178 |
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M.D. Anderson Cancer Center