Health Condition 1: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb
Conditions
Interventions
Intervention1: Pioglitazone: Dose of tablet Pioglitazone (per oral):
Age: 14-17 years- 15 mg twice daily
18 years and above- 15 mg thrice a day
If there is a response, pioglitazone can be continued
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with inoperable recurrent/refractory high-grade osteosarcoma who fail first-line chemotherapy 2. Patients must have normal cardiac function (as assessed by ECG and 2D Echocardiogram) 3. ECOG Performance status 0-3 4. Patients must have normal organ function as defined below: a) total bilirubin b) AST(SGOT)/ALT(SGPT)
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension 2. History of diabetes mellitus 3. Pregnant and lactating women 4. Past history of ischemic heart disease or cardiac failure 5. Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and radiological response assessmentTimepoint: â?¢ For every patient recruited in the study, response will be assessed at 3-months (Thereafter, at 3-monthly intervals until disease progression/ treatment discontinuation or death.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Event-free survival 2. Overall survival 3. Grade 3/4 toxicities Timepoint: â?¢ For every patient recruited in the study, response will be assessed at 3-months (Thereafter, at 3-monthly intervals until disease progression/ treatment discontinuation or death.) â?¢ Survival Endpoints- 1-year follow-up period â?¢ Toxicities will be captured until the conclusion of all treatment (neoadjuvant chemotherapy, surgery and adjuvant chemotherapy) in both arms. Delayed toxicities will be recorded during every follow-up visit. | — |
Countries
India
Contacts
Public ContactDr Nikita Mehra
Cancer Institute WIA
Outcome results
None listed