A study to evaluate the safety and effectiveness of BIOMAB in combination with standard treatments like radio-therapy and drug called Temozolamide in patients with brain tumor
- Conditions
- Health Condition 1: null- Glioblastoma Multiforme
- Registration Number
- CTRI/2013/10/004076
- Lead Sponsor
- Biocon limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
•Willingness by the Patient or Legally acceptable representative (LAR) to sign the informed consent
•Newly diagnosed patients with GBM (Grade 4 Astrocytoma) confirmed by histopathology
•Patients suitable for planned radiotherapy and chemotherapy with TMZ
•Patients who are chemotherapy naive
•Patients aged between 18 - 70 years (both inclusive)
•Karnofskyâ??s Performance Status >= 60%
•Adequate hematological, renal & hepatic function defined as:
•Hb ï?³ 9g/dL, ANC ï?³ 1500/mm3 & Platelet count ï?³ 100,000 /mm3
•Serum creatinine <= 1.5 times ULN for laboratory
•LFT < 3 times ULN for laboratory
•Patients who have undergone debulking surgery or tumor biopsy in the last 4 weeks are eligible for enrollment
•Patients should be willing to use effective methods of contraception during the study
•Female patients who are pregnant or breast feeding
•Patients with severe underlying disease or not controlled by treatment in the opinion of the principal investigator
•HIV, Chronic Hepatitis B or C if found to be positive
•Hypersensitivity to TMZ and BIOMAb-EGFRTM (Nimotuzumab) or any of its components
•Previous or concurrent malignancies in other sites except surgically cured carcinoma-in-situ of cervix & non melanoma skin cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall SurvivalTimepoint: Visit 2 (Day 1) to Visit 105(Day 1852)
- Secondary Outcome Measures
Name Time Method 1 Progression free survival <br/ ><br> <br/ ><br>2 Tumor Response <br/ ><br> <br/ ><br>3 Safety & TolerabilityTimepoint: Visit 2 (Day 1) to Visit 105 (Day 1852) <br/ ><br> <br/ ><br>Visit 11 (Day 68-70), Visit 25 (Day 225-227), Visit 34 (Day 396), <br/ ><br>Visit 42 (Day 564), <br/ ><br>Visit 50 (Day 725), <br/ ><br>Visit 51 to Visit 104 (Every 3 months) <br/ ><br>Visit 105 (Day 1852) <br/ ><br> <br/ ><br>Visit 2 (Day 1) to Visit 105 (Day 1852)