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Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"


Phase 1/Phase 2
8 Years
65 Years
Open (Enrolling)
Both
Osteosarcoma

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Trial Information

Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response, toxicity, disease progression

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

India: Drugs Controller General of India

Study ID:

381

NCT ID:

NCT00689195

Start Date:

May 2008

Completion Date:

June 2013

Related Keywords:

  • Osteosarcoma
  • Curcumin
  • Ashwagandha
  • osteosarcoma
  • Pharmacokinetics of curcumin and ashwagandha formulation
  • response
  • Osteosarcoma

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