Trial Outcomes & Findings for Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma (NCT NCT00200161)
NCT ID: NCT00200161
Last Updated: 2018-03-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
until death or date of last follow up, an average of 12 months
Results posted on
2018-03-07
Participant Flow
85 participants had a Glioblastoma diagnosis. The remaining participants consist of an exploratory cohort of Grade 3 tumors.
Participant milestones
| Measure |
Metronomic Therapy Cohort
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.
|
Dose-Dense Therapy Cohort
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 Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Baseline characteristics by cohort
| Measure |
Metronomic Therapy Cohort
n=43 Participants
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.
|
Dose-Dense Therapy Cohort
n=42 Participants
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
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
n=5 Participants
|
59.1 years
n=7 Participants
|
56.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: until death or date of last follow up, an average of 12 monthsOutcome measures
| Measure |
Metronomic Therapy Cohort
n=43 Participants
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.
|
Dose-Dense Therapy Cohort
n=42 Participants
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.
|
|---|---|---|
|
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.
|
69 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Metronomic Therapy Cohort
n=43 Participants
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.
|
Dose-Dense Therapy Cohort
n=42 Participants
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.
|
|---|---|---|
|
Progression Free Survival at 6 Months
|
46 percentage of participants
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearPopulation: Data were not collected
MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Metronomic Therapy Cohort
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Dose-Dense Therapy Cohort
Serious events: 0 serious events
Other events: 42 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metronomic Therapy Cohort
n=43 participants at risk
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.
|
Dose-Dense Therapy Cohort
n=42 participants at risk
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.
|
|---|---|---|
|
Investigations
Bilirubin
|
51.2%
22/43 • 1 year
|
42.9%
18/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
79.1%
34/43 • 1 year
|
76.2%
32/42 • 1 year
|
|
Investigations
Alkaline Phosphatase
|
23.3%
10/43 • 1 year
|
19.0%
8/42 • 1 year
|
|
Investigations
ALT
|
100.0%
43/43 • 1 year
|
85.7%
36/42 • 1 year
|
|
Investigations
Lymphopenia
|
69.8%
30/43 • 1 year
|
64.3%
27/42 • 1 year
|
|
Investigations
PTT
|
16.3%
7/43 • 1 year
|
19.0%
8/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - right sided
|
4.7%
2/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Left sided
|
4.7%
2/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness extremity - lower
|
0.00%
0/43 • 1 year
|
4.8%
2/42 • 1 year
|
|
Investigations
AST
|
55.8%
24/43 • 1 year
|
33.3%
14/42 • 1 year
|
|
Investigations
Platelets
|
81.4%
35/43 • 1 year
|
64.3%
27/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
79.1%
34/43 • 1 year
|
61.9%
26/42 • 1 year
|
|
Vascular disorders
Thrombosis
|
18.6%
8/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.2%
13/43 • 1 year
|
35.7%
15/42 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
76.7%
33/43 • 1 year
|
54.8%
23/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.9%
12/43 • 1 year
|
28.6%
12/42 • 1 year
|
|
Investigations
Creatinine
|
14.0%
6/43 • 1 year
|
19.0%
8/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.0%
6/43 • 1 year
|
7.1%
3/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.0%
3/43 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
34.9%
15/43 • 1 year
|
33.3%
14/42 • 1 year
|
|
Investigations
INR
|
16.3%
7/43 • 1 year
|
26.2%
11/42 • 1 year
|
|
Nervous system disorders
Seizure
|
9.3%
4/43 • 1 year
|
9.5%
4/42 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43 • 1 year
|
11.9%
5/42 • 1 year
|
|
Nervous system disorders
Headache
|
16.3%
7/43 • 1 year
|
14.3%
6/42 • 1 year
|
|
Renal and urinary disorders
Urinary Frequency
|
4.7%
2/43 • 1 year
|
4.8%
2/42 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytes
|
37.2%
16/43 • 1 year
|
57.1%
24/42 • 1 year
|
|
Investigations
ANC
|
20.9%
9/43 • 1 year
|
31.0%
13/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
4.7%
2/43 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.0%
6/43 • 1 year
|
11.9%
5/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
11.6%
5/43 • 1 year
|
7.1%
3/42 • 1 year
|
|
Investigations
Amylase
|
7.0%
3/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
Investigations
Lipase
|
9.3%
4/43 • 1 year
|
0.00%
0/42 • 1 year
|
|
Infections and infestations
Infection
|
4.7%
2/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
General disorders
Edema: limb
|
0.00%
0/43 • 1 year
|
4.8%
2/42 • 1 year
|
|
General disorders
Fatigue
|
2.3%
1/43 • 1 year
|
7.1%
3/42 • 1 year
|
|
Nervous system disorders
Tremor
|
4.7%
2/43 • 1 year
|
0.00%
0/42 • 1 year
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/43 • 1 year
|
7.1%
3/42 • 1 year
|
|
Investigations
Hypercholesterolemia
|
14.0%
6/43 • 1 year
|
11.9%
5/42 • 1 year
|
|
Nervous system disorders
Speech impairment
|
4.7%
2/43 • 1 year
|
4.8%
2/42 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
2/43 • 1 year
|
2.4%
1/42 • 1 year
|
|
Psychiatric disorders
Depression
|
4.7%
2/43 • 1 year
|
4.8%
2/42 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • 1 year
|
9.5%
4/42 • 1 year
|
|
Eye disorders
Blurred vision
|
2.3%
1/43 • 1 year
|
9.5%
4/42 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/43 • 1 year
|
4.8%
2/42 • 1 year
|
Additional Information
Dr. Lisa Deangelis
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place