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Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050986
Recruitment Status : Completed
First Posted : January 3, 2003
Results First Posted : September 16, 2010
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Drug: Temozolomide
Drug: R115777
Enrollment 55
Recruitment Details Total of 55 participants recruited in between 12/30/2002 and 11/30/2005, all at M. D. Anderson Cancer Center.
Pre-assignment Details 5 patients were not evaluated for response because of the following: 1 early, non-treatment related death; 3 withdrew consent; 1 discontinued for intercurrent illness (pneumonia).
Arm/Group Title Temozolomide and R115777
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 55
Completed 53 [1]
Not Completed 2
[1]
Two participants had withdrawn consents before the study treatment was initiated.
Arm/Group Title Temozolomide and R115777
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
0
   0.0%
Between 18 and 65 years
52
  94.5%
>=65 years
3
   5.5%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 55 participants
52
(21 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
13
  23.6%
Male
42
  76.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Maximal Tolerating Dose (MTD for Phase I)
Hide Description

Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms.

Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily

Time Frame End of first cycle (4 weeks) evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
As treated.
Arm/Group Title Temozolomide and R115777
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Dose Level 1 3
Dose Level 2 3
Dose Level 3 6
Dose Level 4 3
2.Secondary Outcome
Title Progression-free Survival (Phase II)
Hide Description Efficacy measured by 6 month progression-free survival assessment.
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame 2 years, 11 months
Adverse Event Reporting Description Including all serious adverse events regardless of attribution. Including all grade 3 or higher adverse events regardless of attribution.
 
Arm/Group Title Temozolomide and R115777
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Temozolomide and R115777
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Temozolomide and R115777
Affected / at Risk (%) # Events
Total   24/53 (45.28%)    
Blood and lymphatic system disorders   
Neutrophils  1  3/53 (5.66%)  3
Hemoglobin  1  1/53 (1.89%)  1
thrombocytopenia  1  2/53 (3.77%)  2
CNS Hemorrhage  1  1/53 (1.89%)  1
Infections and infestations   
Herpes Zoster  1  2/53 (3.77%)  2
Infection  1  5/53 (9.43%)  5
Metabolism and nutrition disorders   
hypokalemia  1  2/53 (3.77%)  2
hypophasphatemia  1  1/53 (1.89%)  1
Amyliase, Lipase, Pancreatitis  1  1/53 (1.89%)  1
Nervous system disorders   
Seizure  1  3/53 (5.66%)  3
Death  1 [1]  2/53 (3.77%)  2
confusion  1  1/53 (1.89%)  1
Depressed level of consiousness  1  1/53 (1.89%)  1
Pyramidal Tract Dysfunction  1  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  2/53 (3.77%)  2
Vascular disorders   
Thrombosis/embolism  1 [2]  4/53 (7.55%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Due to tumor progression. Not related to the study drugs
[2]
Pulmonary Embolism and deep vein thrombosis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Temozolomide and R115777
Affected / at Risk (%) # Events
Total   47/53 (88.68%)    
Blood and lymphatic system disorders   
Hemoglobin  1  5/53 (9.43%)  6
Neutrophils  1  21/53 (39.62%)  76
Lymphocytopenia  1  40/53 (75.47%)  210
Thrombocytopenia  1  16/53 (30.19%)  30
Thrombosis  1  3/53 (5.66%)  3
Cardiac disorders   
Hypotension  1  1/53 (1.89%)  1
Ear and labyrinth disorders   
Hearing  1  1/53 (1.89%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/53 (1.89%)  1
Anorexia  1  1/53 (1.89%)  1
Constipation  1  2/53 (3.77%)  4
Dehydration  1  2/53 (3.77%)  2
Dry mouth  1  1/53 (1.89%)  1
Nausea  1  1/53 (1.89%)  1
General disorders   
Fatigue  1  7/53 (13.21%)  12
Pain  1  6/53 (11.32%)  8
Weight gain  1  1/53 (1.89%)  1
Weight loss  1  1/53 (1.89%)  1
Metabolism and nutrition disorders   
ALT  1  2/53 (3.77%)  2
Hyperglycemia  1  6/53 (11.32%)  11
Hyperuricemia  1  1/53 (1.89%)  1
Hypoalbuminemia  1  1/53 (1.89%)  1
Hypocalcemia  1  1/53 (1.89%)  1
Hypokalemia  1  2/53 (3.77%)  4
Hyponatremia  1  2/53 (3.77%)  2
Hypophosphatemia  1  4/53 (7.55%)  5
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  4/53 (7.55%)  4
Nervous system disorders   
Ataxia  1  1/53 (1.89%)  1
Mental Status  1  3/53 (5.66%)  3
Motor  1  6/53 (11.32%)  6
Personality/behavioral  1  2/53 (3.77%)  2
Seizures  1  4/53 (7.55%)  4
Speech impairment  1  1/53 (1.89%)  1
Syncope  1  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/53 (1.89%)  1
Hypoxia  1  1/53 (1.89%)  1
Pneumonits  1  4/53 (7.55%)  4
Skin and subcutaneous tissue disorders   
decubitus Ulcer  1  2/53 (3.77%)  2
Pruritus  1  1/53 (1.89%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Mark Gilbert, MD
Organization: University of Texas, M. D. Anderson Cancer Center
EMail: CR_study_registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00050986    
Other Study ID Numbers: ID02-126
First Submitted: December 31, 2002
First Posted: January 3, 2003
Results First Submitted: September 25, 2009
Results First Posted: September 16, 2010
Last Update Posted: August 1, 2012