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Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00580385
Recruitment Status : Recruiting
First Posted : December 24, 2007
Last Update Posted : September 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 20, 2007
December 24, 2007
September 6, 2017
August 1997
August 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00580385 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors
Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors
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. We will also take blood samples before and/or after your procedure to measure biochemical factors that may help us predict the behavior of osteogenic sarcoma and other solid tumors.
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 or has been 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). In addition, blood samples (20ml) may be obtained before or after the procedure.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Osteosarcoma
Biological: Tissue Procurement
MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting
Experimental: 1
Intervention: Biological: Tissue Procurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
August 2018
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with a presumed or known diagnosis of a primary or secondary bone cancer or other solid tumor who are having or have had a biopsy or surgery to remove tumor for diagnostic or therapeutic reasons. No tumors will be obtained solely for research purposes.
  • All adult patients (> or = to 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:

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: John Healey, MD 212-639-7611
United States
 
 
NCT00580385
97-094
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • Hospital for Special Surgery, New York
  • Weill Medical College of Cornell University
  • Columbia University
  • Rockefeller University
Principal Investigator: John Healey, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP