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Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Information source: Tata Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteosarcoma

Intervention: Zoledronic acid (Drug); Standard chemotherapy (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Tata Memorial Hospital

Official(s) and/or principal investigator(s):
Manish Agarwal, M.S(Orth), Principal Investigator, Affiliation: Tata Memorial Hospital

Overall contact:
Manish G Agarwal, M.S(Orth), Phone: 91-22-2444-7189, Email: mgagarwal@gmail.com

Summary

This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years. In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.

Clinical Details

Official title: Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma

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

Primary outcome: histological response disease free interval

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity 2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan. 3. Patients are willing and able to afford the standard chemotherapy. Exclusion Criteria: 1. Non-extremity sarcomas. (pelvis and spine) 2. Age less than 18 years or greater than 65 years 3. Metastatic at presentation 4. Pregnant or lactating women 5. Renal dysfunction in the form of elevated serum creatinine 6. Dental treatment anticipated after evaluation. 7. Patients who have received or are likely to receive steroids.

Locations and Contacts

Manish G Agarwal, M.S(Orth), Phone: 91-22-2444-7189, Email: mgagarwal@gmail.com

Tata Memorial Hospital, Mumbai, Maharashtra 400012, India; Recruiting
Manish G Agarwal, M.S(Orth), Principal Investigator
Additional Information

Starting date: May 2008
Last updated: June 22, 2011

Page last updated: August 23, 2015

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