Pilot Study of Curcumin Formulation and Ashwagandha Extract in Advanced Osteosarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Osteosarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C

Curcumin

Group Type EXPERIMENTAL

Curcumin powder

Intervention Type DIETARY_SUPPLEMENT

oral capsules containing the investigational agent

A

Ashwagandha extract

Group Type EXPERIMENTAL

Ashwagandha extract

Intervention Type DIETARY_SUPPLEMENT

4.5% extract of ashwagandha

Interventions

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Curcumin powder

oral capsules containing the investigational agent

Intervention Type DIETARY_SUPPLEMENT

Ashwagandha extract

4.5% extract of ashwagandha

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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M3CX, Withania somnifera, Dunal, Indian Ginseng

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No