ow dose chemotherapy versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies
Phase 3
- Conditions
- Health Condition 1: null- Refractory Childhood cancer
- Registration Number
- CTRI/2013/06/003734
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with atleast 2 lines of chemotherapy.
2.Good performance status (at least ambulatory patient)
3.Age: 5-18 years
4.Recovered from all acute toxic effects of earlier therapy
5.Absolute neutrophil count > 1X 109/L
6.Absolute platelet count > 75 x 109/L
7.Normal renal functions
8.Serum bilirubin <1.5 times the upper limit of normal, and the serum aspartate aminotransferase and alanine aminotransferase < 5 times the upper limit of normal.
Exclusion Criteria
1.Uncontrolled concurrent illness or active infection
2.Positive serology for human immunodeficiency.
3.Unable to swallow oral medication
4.Pregnant and breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method