celecoxib and Benign Supratentorial Neoplasms studies

Research Excerpts

Excerpt	Relevance	Reference
"External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone."	9.14	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. ( Chang, E; Colman, H; Conrad, C; de Groot, J; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, K; Hunter, K; Levin, V; Mahajan, A; Puduvalli, V; Woo, S; Yung, WK, 2010)
"External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone."	5.14	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. ( Chang, E; Colman, H; Conrad, C; de Groot, J; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, K; Hunter, K; Levin, V; Mahajan, A; Puduvalli, V; Woo, S; Yung, WK, 2010)

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Gilbert, MR	1
Gonzalez, J	1
Hunter, K	1
Hess, K	1
Giglio, P	1
Chang, E	1
Puduvalli, V	1
Groves, MD	1
Colman, H	1
Conrad, C	1
Levin, V	1
Woo, S	1
Mahajan, A	1
de Groot, J	1
Yung, WK	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
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[NCT00112502]	Phase 2	178 participants (Actual)	Interventional	2005-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy

Intervention	months (Median)
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII	20.2
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII	17.1

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). (NCT00112502)
Timeframe: 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

Intervention	months (Median)
Doublet (2 Agents): Arm II, Arm III and Arm IV	17.0
Triplet (3 Agents): Arm V, Arm VI and Arm VII	20.1

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). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms

Intervention	months (Median)
Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII	17.1
No Isotretinoin: Arm I, Arm II, Arm III and ARM VI	19.9

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). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms

Intervention	months (Median)
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII	18.3
No Thalidomide: Arm I, Arm III, Arm IV and Arm V	17.4

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). (NCT00112502)
Timeframe: 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

Intervention	months (Median)
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII	8.3
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII	7.4

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). (NCT00112502)
Timeframe: 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

Intervention	months (Median)
Doublet (2 Agents): Arm II, Arm III and Arm IV	8.3
Triplet (3 Agents): Arm V, Arm VI and Arm VII	8.2

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). (NCT00112502)
Timeframe: 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 Thalidomide Arms Versus no Thalidomide Arms

Intervention	months (Median)
Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII	6.6
No Isotretinoin: Arm I, Arm II, Arm III and Arm VI	9.1

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). (NCT00112502)
Timeframe: 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) of Individual Arms

Intervention	months (Median)
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII	7.6
No Thalidomide: Arm I, Arm III, Arm IV and Arm V	8.7

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). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.

Overall Survival of Individual Arms

Intervention	months (Median)
Arm I: TMZ	10.5
Arm II: TMZ + Thalidomide	7.7
Arm III: TMZ + Celecoxib	13.4
Arm IV: TMZ + Isotretinoin	6.5
Arm V: TMZ + Isotretinoin + Celecoxib	11.6
Arm VI: TMZ + Thalidomide + Celecoxib	7.9
Arm VII: TMZ + Thalidomide + Isotretinoin	6.2
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib	5.8

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). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Intervention	months (Median)
Arm I: TMZ	21.2
Arm II: TMZ + Thalidomide	17.4
Arm III: TMZ + Celecoxib	18.1
Arm IV: TMZ + Isotretinoin	11.7
Arm V: TMZ + Isotretinoin + Celecoxib	23.1
Arm VI: TMZ + Thalidomide + Celecoxib	20.2
Arm VII: TMZ + Thalidomide + Isotretinoin	17.9
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib	18.5