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

June 22, 2011 updated by: Tata Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Manish Agarwal, M.S(Orth), D.N.B(Orth)
  • Phone Number: 91-22-2444-7189
  • Email: mgagarwal@gmail.com

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manish Agarwal, M.S(Orth)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C
Curcumin
Dietary supplement: Curcumin powder
oral capsules containing the investigational agent
Other Names:
  • M3CX,
Experimental: A
Ashwagandha extract
Dietary supplement: Ashwagandha extract
4.5% extract of ashwagandha
Other Names:
  • Withania somnifera,
  • Dunal,
  • Indian Ginseng

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response, toxicity, disease progression
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Collaborators

Pharmanza Herbals Pvt Limited (PHPL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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