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Trial record 93 of 163 for:    ISOTRETINOIN

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

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ClinicalTrials.gov Identifier: NCT00200161
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Schering-Plough
Columbia University
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Gliomas
Intervention Drug: Temozolomide
Enrollment 127
Recruitment Details  
Pre-assignment Details

85 participants had a Glioblastoma diagnosis.

The remaining participants consist of an exploratory cohort of Grade 3 tumors.

Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Period Title: Overall Study
Started 43 42
Completed 43 42
Not Completed 0 0
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort Total
Hide Arm/Group Description

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Total of all reporting groups
Overall Number of Baseline Participants 43 42 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 85 participants
54.1
(21 to 71)
59.1
(30 to 70)
56.3
(21 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Female
27
  62.8%
29
  69.0%
56
  65.9%
Male
16
  37.2%
13
  31.0%
29
  34.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
42
  97.7%
40
  95.2%
82
  96.5%
Unknown or Not Reported
1
   2.3%
2
   4.8%
3
   3.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
American Indian or Alaska Native
0
   0.0%
1
   2.4%
1
   1.2%
Asian
3
   7.0%
1
   2.4%
4
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.7%
1
   2.4%
3
   3.5%
White
37
  86.0%
37
  88.1%
74
  87.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.3%
2
   4.8%
3
   3.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 43 participants 42 participants 85 participants
43
 100.0%
42
 100.0%
85
 100.0%
1.Primary Outcome
Title 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.
Hide Description [Not Specified]
Time Frame until death or date of last follow up, an average of 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description:

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Overall Number of Participants Analyzed 43 42
Measure Type: Number
Unit of Measure: percentage of participants
69 80
2.Secondary Outcome
Title Progression Free Survival at 6 Months
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description:

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Overall Number of Participants Analyzed 43 42
Measure Type: Number
Unit of Measure: percentage of participants
46 56
3.Secondary Outcome
Title Prognostic Impact of Methylated MGMT Status.
Hide Description MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.
Time Frame through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description:

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.
Hide Description [Not Specified]
Time Frame through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description:

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Hide Arm/Group Description

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

All-Cause Mortality
Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   1/42 (2.38%) 
Show Serious Adverse Events Hide Serious Adverse Events
Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metronomic Therapy Cohort Dose-Dense Therapy Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   43/43 (100.00%)   42/42 (100.00%) 
Blood and lymphatic system disorders     
Hemoglobin   33/43 (76.74%)  23/42 (54.76%) 
Leukocytes   16/43 (37.21%)  24/42 (57.14%) 
Eye disorders     
Blurred vision   1/43 (2.33%)  4/42 (9.52%) 
Gastrointestinal disorders     
Constipation   5/43 (11.63%)  5/42 (11.90%) 
General disorders     
Edema: limb   0/43 (0.00%)  2/42 (4.76%) 
Fatigue   11/43 (25.58%)  20/42 (47.62%) 
Fatigue   1/43 (2.33%)  3/42 (7.14%) 
Infections and infestations     
Infection   2/43 (4.65%)  1/42 (2.38%) 
Investigations     
Bilirubin   22/43 (51.16%)  18/42 (42.86%) 
Alkaline Phosphatase   10/43 (23.26%)  8/42 (19.05%) 
ALT   43/43 (100.00%)  36/42 (85.71%) 
Lymphopenia   30/43 (69.77%)  27/42 (64.29%) 
PTT   7/43 (16.28%)  8/42 (19.05%) 
AST   24/43 (55.81%)  14/42 (33.33%) 
Platelets   35/43 (81.40%)  27/42 (64.29%) 
Creatinine   6/43 (13.95%)  8/42 (19.05%) 
INR   7/43 (16.28%)  11/42 (26.19%) 
ANC   9/43 (20.93%)  13/42 (30.95%) 
Amylase   3/43 (6.98%)  1/42 (2.38%) 
Lipase   4/43 (9.30%)  0/42 (0.00%) 
Hypercholesterolemia   6/43 (13.95%)  5/42 (11.90%) 
Metabolism and nutrition disorders     
Hyperglycemia   34/43 (79.07%)  32/42 (76.19%) 
Hypoalbuminemia   34/43 (79.07%)  26/42 (61.90%) 
Hyponatremia   13/43 (30.23%)  15/42 (35.71%) 
Hypokalemia   12/43 (27.91%)  12/42 (28.57%) 
Hyperkalemia   6/43 (13.95%)  3/42 (7.14%) 
Hypermagnesemia   3/43 (6.98%)  0/42 (0.00%) 
Hypernatremia   15/43 (34.88%)  14/42 (33.33%) 
Hypomagnesmia   2/43 (4.65%)  0/42 (0.00%) 
Hypophosphatemia   6/43 (13.95%)  5/42 (11.90%) 
Hypertriglyceridemia   5/43 (11.63%)  3/42 (7.14%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness - right sided   2/43 (4.65%)  1/42 (2.38%) 
Muscle weakness - Left sided   2/43 (4.65%)  1/42 (2.38%) 
Muscle weakness extremity - lower   0/43 (0.00%)  2/42 (4.76%) 
Nervous system disorders     
Seizure   4/43 (9.30%)  4/42 (9.52%) 
Headache   7/43 (16.28%)  6/42 (14.29%) 
Tremor   2/43 (4.65%)  0/42 (0.00%) 
Speech impairment   2/43 (4.65%)  2/42 (4.76%) 
Psychiatric disorders     
Insomnia   1/43 (2.33%)  3/42 (7.14%) 
Depression   2/43 (4.65%)  2/42 (4.76%) 
Confusion   0/43 (0.00%)  2/42 (4.76%) 
Renal and urinary disorders     
Urinary Frequency   2/43 (4.65%)  2/42 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough   2/43 (4.65%)  1/42 (2.38%) 
Skin and subcutaneous tissue disorders     
Alopecia   1/43 (2.33%)  4/42 (9.52%) 
Vascular disorders     
Thrombosis   8/43 (18.60%)  1/42 (2.38%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lisa Deangelis
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-7997
EMail: deangell@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00200161     History of Changes
Other Study ID Numbers: 05-079
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: January 10, 2018
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018