Study to determine the response of Curcumin and Ashwagandha in high grade osteosarcoma

Phase 1

Completed

Conditions: Health Condition 1: null- Advanced high grade Osteosarcoma of bone (extremities)

Registration Number: CTRI/2011/091/000187

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1.Patients (between the ages of 8 to 65 years) with histologically proven high grade osteosarcoma of the extremity and relapsed disease after primary line of treatment who are unsuitable or refuse secondary chemotherapy.

2.Patients with advanced disease unable or unwilling to take primary conventional treatment

3.Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.

4.Adequate hepatic function defined by total bilirubin not more than 1.5 times the upper limit of normal (ULN) and SGOT and SGPT not more than 2.5 times the (ULN)

5.Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by Cockcroft-Gault formula

Exclusion Criteria

1.Patients who are suitable for second line chemotherapy and can afford it
2.Age less than 8 years or greater than 65 years
3.Pregnant or lactating women
4.Patients who are unable or unwilling to provide blood samples for the drug assays.
5.Low grade osteosarcoma
6.Participation in any investigational drug study within 28 days prior to study treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In Vitro <br/ ><br>1.To get formulation of curcumin & Ashwagandha prepared <br/ ><br>2.To establish indigenous cell lines for osteosarcoma for future lab studies (studying the combination of curcumin & Ashwagandha <br/ ><br> <br/ ><br>In Vivo-in human patients with advanced metastatic osteosarcoma who have exhausted their treatment options <br/ ><br>3.To study the pharmacokinetics of curcumin & Ashwagandha <br/ ><br>4.To establish a dose requirement for curcumin-piperine & Ashwagandha <br/ ><br>5.To test the efficacy & safety of curcumin & AshwagandhaTimepoint: 4 years

Secondary Outcome Measures