Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma (OSCAT)

Tata Memorial Hospital

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Osteosarcoma

Treatments

Dietary Supplement: Ashwagandha extract

Dietary Supplement: Curcumin powder

Study type

Interventional

Funder types

Other

Identifiers

NCT00689195

381

Details and patient eligibility

About

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.

Full description

Eligibility criteria

Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.
Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests

Enrollment

24 estimated patients

Sex

All

Ages

8 to 65 years old

Volunteers

No Healthy Volunteers

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.