Trial Outcomes & Findings for Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas (NCT NCT00412542)
NCT ID: NCT00412542
Last Updated: 2012-02-28
Results Overview
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
6 Months
Results posted on
2012-02-28
Participant Flow
Recruitment Period: October 13, 2003 to October 22, 2008. All participants were recruited at UT MD Anderson Cancer Center.
Of the 78 participants enrolled, three (3) were considered not evaluable.
Participant milestones
| Measure |
Glioblastoma Multiforme: Thalidomide + CPT-11
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
Anaplastic Gliomas: Thalidomide + CPT-11
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
45
|
|
Overall Study
COMPLETED
|
33
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Glioblastoma Multiforme: Thalidomide + CPT-11
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
Anaplastic Gliomas: Thalidomide + CPT-11
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Not Eligible
|
0
|
1
|
Baseline Characteristics
Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas
Baseline characteristics by cohort
| Measure |
Glioblastoma Multiforme: Thalidomide + CPT-11
n=33 Participants
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
Anaplastic Gliomas: Thalidomide + CPT-11
n=45 Participants
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
45 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: 7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Outcome measures
| Measure |
Participants With Recurrent Malignant Gliomas
n=68 Participants
The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
|
|---|---|
|
Number of Participants Progression Free at 6 Months With Malignant Gliomas
|
24 participants
|
Adverse Events
Patients With Recurrent Malignant Gliomas
Serious events: 35 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Recurrent Malignant Gliomas
n=75 participants at risk
The endpoints combined results of all strata
|
|---|---|
|
Vascular disorders
Thrombus pulmonary embolus
|
6.7%
5/75 • Number of events 5 • 4 years and 11 months
|
|
Nervous system disorders
Seizure
|
10.7%
8/75 • Number of events 11 • 4 years and 11 months
|
|
Gastrointestinal disorders
Nausea
|
4.0%
3/75 • Number of events 3 • 4 years and 11 months
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • Number of events 4 • 4 years and 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
9/75 • Number of events 10 • 4 years and 11 months
|
|
Nervous system disorders
Ataxia
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
Cerebral edema
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Gastrointestinal disorders
Colitis
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Psychiatric disorders
Confusion
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
8.0%
6/75 • Number of events 6 • 4 years and 11 months
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
5/75 • Number of events 6 • 4 years and 11 months
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Vascular disorders
Thrombus - deep vein thrombosis
|
8.0%
6/75 • Number of events 6 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Investigations
Elevated ALT
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Investigations
Elevated Creatinine
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
Enteritis
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
General disorders
Fatigue
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
General disorders
Fever
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Nervous system disorders
Hydrocephalus
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Investigations
Hyperglycemia
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Vascular disorders
Hypotension
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Infections and infestations
Infection
|
4.0%
3/75 • Number of events 3 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
2/75 • Number of events 2 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Musculo-skeletal leg cramps
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
5/75 • Number of events 5 • 4 years and 11 months
|
|
Infections and infestations
Pneumonia
|
4.0%
3/75 • Number of events 3 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
Somnolence
|
4.0%
3/75 • Number of events 3 • 4 years and 11 months
|
|
Injury, poisoning and procedural complications
Subdural fluid collection
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
1/75 • Number of events 1 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
4.0%
3/75 • Number of events 3 • 4 years and 11 months
|
Other adverse events
| Measure |
Patients With Recurrent Malignant Gliomas
n=75 participants at risk
The endpoints combined results of all strata
|
|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
12.0%
9/75 • Number of events 18 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.0%
12/75 • Number of events 17 • 4 years and 11 months
|
|
Investigations
Alkaline Phosphatase increased
|
14.7%
11/75 • Number of events 18 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.7%
11/75 • Number of events 16 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.3%
13/75 • Number of events 13 • 4 years and 11 months
|
|
Investigations
ALT increased
|
22.7%
17/75 • Number of events 40 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
5/75 • Number of events 11 • 4 years and 11 months
|
|
Gastrointestinal disorders
Anorexia
|
29.3%
22/75 • Number of events 25 • 4 years and 11 months
|
|
Investigations
AST elevated
|
16.0%
12/75 • Number of events 19 • 4 years and 11 months
|
|
Nervous system disorders
Ataxia
|
8.0%
6/75 • Number of events 9 • 4 years and 11 months
|
|
Investigations
Bicarbonate sodium, low
|
21.3%
16/75 • Number of events 30 • 4 years and 11 months
|
|
Investigations
Bilirubin elevated
|
6.7%
5/75 • Number of events 5 • 4 years and 11 months
|
|
Eye disorders
Blurred vision
|
16.0%
12/75 • Number of events 19 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Bruising (without thrombocytopenia)
|
6.7%
5/75 • Number of events 5 • 4 years and 11 months
|
|
Investigations
BUN elevated
|
16.0%
12/75 • Number of events 20 • 4 years and 11 months
|
|
Investigations
Cholesterol elevated
|
14.7%
11/75 • Number of events 11 • 4 years and 11 months
|
|
Nervous system disorders
Cognitive disturbance
|
10.7%
8/75 • Number of events 8 • 4 years and 11 months
|
|
Psychiatric disorders
Confusion
|
21.3%
16/75 • Number of events 22 • 4 years and 11 months
|
|
Gastrointestinal disorders
Constipation
|
61.3%
46/75 • Number of events 91 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.0%
24/75 • Number of events 33 • 4 years and 11 months
|
|
Investigations
CPK elevated
|
5.3%
4/75 • Number of events 5 • 4 years and 11 months
|
|
Investigations
Creatinine elevated
|
12.0%
9/75 • Number of events 11 • 4 years and 11 months
|
|
Endocrine disorders
Cushingoid
|
14.7%
11/75 • Number of events 11 • 4 years and 11 months
|
|
Gastrointestinal disorders
Dehydration
|
18.7%
14/75 • Number of events 16 • 4 years and 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
61.3%
46/75 • Number of events 171 • 4 years and 11 months
|
|
Nervous system disorders
Dizziness
|
42.7%
32/75 • Number of events 55 • 4 years and 11 months
|
|
General disorders
Dry mouth
|
12.0%
9/75 • Number of events 13 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.3%
16/75 • Number of events 17 • 4 years and 11 months
|
|
Nervous system disorders
Dysphasia
|
6.7%
5/75 • Number of events 5 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.3%
16/75 • Number of events 21 • 4 years and 11 months
|
|
General disorders
Edema
|
41.3%
31/75 • Number of events 42 • 4 years and 11 months
|
|
Investigations
Elevated chloride
|
24.0%
18/75 • Number of events 38 • 4 years and 11 months
|
|
Investigations
Elevated CO2
|
18.7%
14/75 • Number of events 27 • 4 years and 11 months
|
|
Investigations
Elevated AST
|
8.0%
6/75 • Number of events 8 • 4 years and 11 months
|
|
General disorders
Fatigue
|
84.0%
63/75 • Number of events 143 • 4 years and 11 months
|
|
General disorders
Fever without neutropenia
|
14.7%
11/75 • Number of events 16 • 4 years and 11 months
|
|
Nervous system disorders
Gait/walking
|
41.3%
31/75 • Number of events 37 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Anemia/decreased hemoglobin
|
76.0%
57/75 • Number of events 195 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
65.3%
49/75 • Number of events 130 • 4 years and 11 months
|
|
Investigations
Hyperuricemia
|
9.3%
7/75 • Number of events 9 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.7%
23/75 • Number of events 53 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.0%
21/75 • Number of events 57 • 4 years and 11 months
|
|
Investigations
Hypokalemia
|
32.0%
24/75 • Number of events 47 • 4 years and 11 months
|
|
Investigations
Hypomagnesium
|
17.3%
13/75 • Number of events 16 • 4 years and 11 months
|
|
Investigations
Hyponatremia
|
25.3%
19/75 • Number of events 34 • 4 years and 11 months
|
|
Investigations
Hypophosphatemia
|
32.0%
24/75 • Number of events 56 • 4 years and 11 months
|
|
Vascular disorders
Hypotension
|
12.0%
9/75 • Number of events 10 • 4 years and 11 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
10.7%
8/75 • Number of events 8 • 4 years and 11 months
|
|
Infections and infestations
Infection
|
30.7%
23/75 • Number of events 26 • 4 years and 11 months
|
|
General disorders
Insomnia
|
24.0%
18/75 • Number of events 24 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
86.7%
65/75 • Number of events 315 • 4 years and 11 months
|
|
Investigations
Low protein
|
20.0%
15/75 • Number of events 21 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
69.3%
52/75 • Number of events 284 • 4 years and 11 months
|
|
Nervous system disorders
Memory Impairment
|
34.7%
26/75 • Number of events 29 • 4 years and 11 months
|
|
Psychiatric disorders
Mood alteration
|
24.0%
18/75 • Number of events 20 • 4 years and 11 months
|
|
Gastrointestinal disorders
Mucositis
|
13.3%
10/75 • Number of events 13 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower extremity
|
33.3%
25/75 • Number of events 36 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness facial
|
8.0%
6/75 • Number of events 7 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left or right sides
|
9.3%
7/75 • Number of events 7 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness generalized
|
20.0%
15/75 • Number of events 21 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/paranasal reactions
|
8.0%
6/75 • Number of events 7 • 4 years and 11 months
|
|
Gastrointestinal disorders
Nausea
|
50.7%
38/75 • Number of events 119 • 4 years and 11 months
|
|
Nervous system disorders
Neuropathy motor
|
14.7%
11/75 • Number of events 14 • 4 years and 11 months
|
|
Nervous system disorders
Neuropathy sensory
|
46.7%
35/75 • Number of events 52 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Neutrophils, absolute count
|
73.3%
55/75 • Number of events 249 • 4 years and 11 months
|
|
Gastrointestinal disorders
Pain, abdominal
|
22.7%
17/75 • Number of events 34 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
8.0%
6/75 • Number of events 7 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain, chest (non cardiac)
|
8.0%
6/75 • Number of events 7 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain, extremity
|
12.0%
9/75 • Number of events 18 • 4 years and 11 months
|
|
Nervous system disorders
Pain, headache
|
52.0%
39/75 • Number of events 75 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
25/75 • Number of events 52 • 4 years and 11 months
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
25.3%
19/75 • Number of events 27 • 4 years and 11 months
|
|
Nervous system disorders
Seizure
|
33.3%
25/75 • Number of events 48 • 4 years and 11 months
|
|
Nervous system disorders
Somnolence
|
26.7%
20/75 • Number of events 25 • 4 years and 11 months
|
|
Nervous system disorders
Speech impairment
|
25.3%
19/75 • Number of events 28 • 4 years and 11 months
|
|
Nervous system disorders
Tremors
|
24.0%
18/75 • Number of events 22 • 4 years and 11 months
|
|
Renal and urinary disorders
Urinary frequency
|
17.3%
13/75 • Number of events 13 • 4 years and 11 months
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
22/75 • Number of events 57 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
Weight gain
|
13.3%
10/75 • Number of events 12 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
Weight loss
|
16.0%
12/75 • Number of events 15 • 4 years and 11 months
|
Additional Information
Vinay Puduvalli, MD / Associate Professor
UT MD Anderson Cancer Center
Phone: 713-745-5769
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place