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

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ClinicalTrials.gov Identifier: NCT00691236
Recruitment Status : Unknown
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 5, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Tata Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Zoledronic acid Drug: Standard chemotherapy Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Study Start Date : May 2008
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
Other Names:
  • Doxorubicin
  • Holoxan
Experimental: B
zoledronic acid prior to standard chemotherapy
Drug: Zoledronic acid
4mg IV 3 weekly for 6 doses
Other Names:
  • Zolendron,
  • Zometa
Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
Other Names:
  • Doxorubicin
  • Holoxan
Experimental: C
zoledronic acid alone 4mg IV 3 weekly for 6 doses
Drug: Zoledronic acid
4mg IV 3 weekly for 6 doses
Other Names:
  • Zolendron,
  • Zometa



Primary Outcome Measures :
  1. histological response disease free interval [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691236


Contacts
Contact: Manish G Agarwal, M.S(Orth) 91-22-2444-7189 mgagarwal@gmail.com
Contact: Ajay Puri, M.S(Orth) 91-22-2417-7183 docpuri@vsnl.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Principal Investigator: Manish G Agarwal, M.S(Orth)         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Manish Agarwal, M.S(Orth) Tata Memorial Hospital

Responsible Party: Dr Manish Agarwal, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00691236     History of Changes
Other Study ID Numbers: 382
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Tata Memorial Hospital:
osteosarcoma
zoledronic acid
bisphosphonates
adjuvant to chemotherapy

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs