Clinical Trial: Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma

This study is currently recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, doxorubicin, and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pamidronate with chemotherapy may prevent bone metastases and reduce the chance of bone replacement problems by strengthening bones in patients who are undergoing surgery for osteosarcoma.

PURPOSE: Phase II trial to study the effectiveness of combining neoadjuvant and adjuvant pamidronate with induction and maintenance chemotherapy in treating patients who have newly diagnosed osteosarcoma.

Condition Treatment or Intervention Phase
localized osteosarcoma
metastatic osteosarcoma
 Drug: cisplatin
 Drug: doxorubicin
 Drug: methotrexate
 Drug: pamidronate
 Procedure: adjuvant therapy
 Procedure: bone metastases prevention
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: high-dose chemotherapy
 Procedure: hypercalcemia therapy
 Procedure: neoadjuvant therapy
 Procedure: supportive care/therapy
 Procedure: surgery
Phase II

MedlinePlus related topics:  Bone Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Neoadjuvant/Adjuvant Study of Pamidronate With Standard Induction and Maintenance Chemotherapy in Patients With Newly Diagnosed High-Grade Osteosarcoma

Further Study Details: 

OBJECTIVES:

  • Determine the safety and feasibility of pamidronate with standard induction and maintenance chemotherapy in patients with newly diagnosed high-grade osteosarcoma.
  • Determine the frequency of favorable tumor necrosis produced in patients treated with this regimen.
  • Determine the event-free survival of patients without metastatic disease at presentation treated with this regimen.
  • Determine the prosthesis failure-free survival of patients treated with this regimen and who ultimately undergo limb preservation surgery with insertion of an endoprosthesis.

OUTLINE: Patients are stratified according to extent of disease (localized vs metastatic).

PROJECTED ACCRUAL: A total of 75 patients (50 with localized disease; 25 with metastatic disease) will be accrued for this study within 3-4 years.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade osteosarcoma
  • Newly diagnosed
  • Previously untreated
  • Prior definitive surgical resection of primary tumor allowed
  • No history of Paget's disease

PATIENT CHARACTERISTICS: Age

  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil at least 1,000/mm^3

Hepatic

  • AST no greater than 3 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • Shortening fraction at least 28% by echocardiogram OR
  • Ejection fraction at least 50% by radionuclide angiogram
  • No history of pericarditis or myocarditis
  • No history of symptomatic arrhythmia
  • No history of symptomatic cardiac conduction abnormalities

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of other cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No prior treatment for cancer
  • No concurrent enrollment on another therapeutic study

Location and Contact Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
John H. Healey, MD  212-639-7610    healeyj@mskcc.org 

Study chairs or principal investigators

Paul A. Meyers, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000339591; MSKCC-03074; NCT00072306
Record last reviewed:  October 2003
Last Updated:  December 6, 2004
Record first received:  November 4, 2003
ClinicalTrials.gov Identifier:  NCT00072306
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005