Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

NCT00689195 | Unknown Phase 1 DMC

• 1 other identifier: 381
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma

Keywords

Curcumin; Ashwagandha; osteosarcoma; Pharmacokinetics of curcumin and ashwagandha formulation; response

Outcome Measures

Primary Outcomes (1)

• response, toxicity, disease progression

  2 years

Secondary Outcomes (1)

• quality of life

  2 years

Study Arms (2)

C

EXPERIMENTAL

Curcumin

Dietary Supplement: Curcumin powder

A

EXPERIMENTAL

Ashwagandha extract

Dietary Supplement: Ashwagandha extract

Interventions

Curcumin powder DIETARY_SUPPLEMENT

oral capsules containing the investigational agent

Also known as: M3CX,

C

Ashwagandha extract DIETARY_SUPPLEMENT

4.5% extract of ashwagandha

Also known as: Withania somnifera,, Dunal,, Indian Ginseng

A

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Pharmanza Herbals Pvt Limited (PHPL): collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Manish Agarwal, M.S(Orth), D.N.B(Orth)

CONTACT

91-22-2444-7189; mgagarwal@gmail.com

Vikram S Gota, M.D

CONTACT

91-22-2417-7000; vikramgota@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: June 3, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

IN (1)