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

Primary Purpose

Osteosarcoma

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Curcumin powder
Ashwagandha extract
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response

Eligibility Criteria

8 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tata Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

C

A

Arm Description

Curcumin

Ashwagandha extract

Outcomes

Primary Outcome Measures

response, toxicity, disease progression

Secondary Outcome Measures

quality of life

Full Information

First Posted
May 23, 2008
Last Updated
June 22, 2011
Sponsor
Tata Memorial Hospital
Collaborators
Pharmanza Herbals Pvt Limited (PHPL)
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1. Study Identification

Unique Protocol Identification Number
NCT00689195
Brief Title
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
Acronym
OSCAT
Official Title
Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tata Memorial Hospital
Collaborators
Pharmanza Herbals Pvt Limited (PHPL)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
Curcumin, Ashwagandha, osteosarcoma, Pharmacokinetics of curcumin and ashwagandha formulation, response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C
Arm Type
Experimental
Arm Description
Curcumin
Arm Title
A
Arm Type
Experimental
Arm Description
Ashwagandha extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin powder
Other Intervention Name(s)
M3CX,
Intervention Description
oral capsules containing the investigational agent
Intervention Type
Dietary Supplement
Intervention Name(s)
Ashwagandha extract
Other Intervention Name(s)
Withania somnifera,, Dunal,, Indian Ginseng
Intervention Description
4.5% extract of ashwagandha
Primary Outcome Measure Information:
Title
response, toxicity, disease progression
Time Frame
2 years
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manish Agarwal, M.S(Orth), D.N.B(Orth)
Phone
91-22-2444-7189
Email
mgagarwal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vikram S Gota, M.D
Phone
91-22-2417-7000
Ext
4537
Email
vikramgota@gmail.com
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Agarwal, M.S(Orth)
Phone
91-22-2444-7189
Email
mgagarwal@gmail.com
First Name & Middle Initial & Last Name & Degree
Vikram S Gota, M.D
Phone
91-22-2417-7000
Ext
4537
Email
vikramgota@gmail.com
First Name & Middle Initial & Last Name & Degree
Manish Agarwal, M.S(Orth)

12. IPD Sharing Statement

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Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

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