Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Hospital for Special Surgery, New York
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00580385

Purpose

The purpose of this study is to investigate tumors in the laboratory to determine how and why they respond, or fail to respond to different drug therapies. This study will also investigate why high pressure develops within tumors and how this affects how well drugs work.

Condition	Intervention
Osteosarcoma	Biological: Tissue Procurement

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To test tumor samples obtained from patients with primary or secondary bone cancer for mechanisms of acquired and intrinsic resistance to methotrexate and to relate these findings to histologic response to preoperative chemotherapy and outcome. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To attempt to grow these tumor cells in short term culture to test the sensitivity of these cells to chemotherapeutic agents and to correlate cytotoxicity with biochemical and molecular studies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 1997
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Tissue Procurement MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting

Detailed Description:

When tumor tissue known or presumed to be a primary or secondary bone cancer or solid tumor with known elevated intra-tumoral pressure such as retinoblastoma is being removed for diagnostic or therapeutic reasons a small sample of it will be obtained for this study. The tumor samples will be used to study in vitro, determinants of chemotherapy resistance and oncogenesis. These determinants will be correlated with histologic response to preoperative chemotherapy and clinical outcome (event free survival).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with a presumed or known diagnosis of a primary or secondary bone cancer who are having surgery to remove tumor for diagnostic or therapeutic reasons. No tumors will be obtained solely for research purposes.
All adult patients (>18 yrs.) will have given written informed consent.
All minor patients (<18 yrs.) will have given assent to the best of their ability to understand, and their parent or guardian will have given written informed consent

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580385

Contacts

Contact: John Healey, MD

healeyj@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Hospital for Special Surgery, New York

Investigators

Principal Investigator:

John Healey, MD

Memorial Sloan-Kettering Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( John Healey, MD )
Study ID Numbers:	97-094
Study First Received:	December 20, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00580385
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

BONE

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma

Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 13, 2009