Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

Phase 1

• Conditions: Osteosarcoma
• Interventions: Dietary Supplement: Curcumin powder; Dietary Supplement: Ashwagandha extract

• Registration Number: NCT00689195
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine and have been shown to be potent anti-cancer compounds in laboratory as well as animal studies. This study will test the safety and efficacy of a curcumin formulation and the ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second line chemotherapy is being given. The pharmacokinetics will be studied along with response as measured on CT scans and PET scans as well as the quality of life and any toxicity.

Detailed Description

Eligibility criteria

1. Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.

2. Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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.
• Patients with advanced disease unable or unwilling to take primary conventional treatment
• Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.
• 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)
• Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by cockcroft-Gault formula

Exclusion Criteria

• Patients who are suitable for second line chemotherapy and can afford it
• Age less than 8 years or greater than 65 years
• Pregnant or lactating women
• Patients who are unable or unwilling to provide blood samples for the drug assays.
• Low grade osteosarcoma
• Patient requiring treatment with CYP3A4 inducers or inhibitors (patients on treatment for epilepsy or tuberculosis)
• Participation in any investigational drug study within 28 days prior to study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Curcumin powder	Curcumin
A	Ashwagandha extract	Ashwagandha extract

Primary Outcome Measures

Name	Time	Method
response, toxicity, disease progression	2 years

Secondary Outcome Measures

Name	Time	Method
quality of life	2 years

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India