Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-28 @ 8:41 AM
Study NCT ID:
NCT00689195
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma
Sponsor:
Tata Memorial Hospital
Organization:
Study Overview
Official Title:
Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSCAT
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
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: