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

Osteosarcoma Clinical Trial

— ZOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00691236
• Other study ID #: 382
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 27, 2008
• Last updated: June 22, 2011
• Start date: May 2008
• Est. completion date: August 2013

Study information

• Verified date: June 2011
• Source: Tata Memorial Hospital
• Contact: Manish G Agarwal, M.S(Orth)
• Phone: 91-22-2444-7189
• Email: mgagarwal[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Zoledronic acid
4mg IV 3 weekly for 6 doses
• Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological response disease free interval		2 years	No