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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Pharmanza Herbals Pvt Limited (PHPL)
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00689195
First received: May 23, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose
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.

Condition Intervention Phase
Osteosarcoma
Dietary Supplement: Curcumin powder
Dietary Supplement: Ashwagandha extract
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • response, toxicity, disease progression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C
Curcumin
Dietary Supplement: Curcumin powder
oral capsules containing the investigational agent
Other Name: M3CX,
Experimental: A
Ashwagandha extract
Dietary Supplement: Ashwagandha extract
4.5% extract of ashwagandha
Other Names:
  • Withania somnifera,
  • Dunal,
  • Indian Ginseng

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
  Eligibility

Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689195

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Pharmanza Herbals Pvt Limited (PHPL)
  More Information

Responsible Party: Dr Manish Agarwal, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00689195     History of Changes
Other Study ID Numbers: 381 
Study First Received: May 23, 2008
Last Updated: June 22, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Tata Memorial Hospital:
Curcumin
Ashwagandha
osteosarcoma
Pharmacokinetics of curcumin and ashwagandha formulation
response

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016