Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

Osteosarcoma Clinical Trial

— OSCAT  

Official title:

Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00689195
• Other study ID #: 381
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 23, 2008
• Last updated: June 22, 2011
• Start date: May 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Tata Memorial Hospital
• Contact: Manish Agarwal, M.S(Orth), D.N.B(Orth)
• Phone: 91-22-2444-7189
• Email: mgagarwal[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Dietary Supplement:
• Curcumin powder
oral capsules containing the investigational agent
• Ashwagandha extract
4.5% extract of ashwagandha

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Tata Memorial Hospital	Pharmanza Herbals Pvt Limited (PHPL)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response, toxicity, disease progression		2 years	Yes
Secondary	quality of life		2 years	No