Status:
UNKNOWN
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
Lead Sponsor:
Tata Memorial Hospital
Collaborating Sponsors:
Pharmanza Herbals Pvt Limited (PHPL)
Conditions:
Osteosarcoma
Eligibility:
All Genders
8-65 years
Phase:
PHASE1
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00689195
Start Date
May 1 2008
End Date
June 1 2013
Last Update
June 23 2011
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012