Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

NCT00580385 — Not applicable, Active not recruiting, 763 participants, Memorial Sloan Kettering Cancer Center

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Registry	NCT00580385
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	763 (Actual)
Sponsor	Memorial Sloan Kettering Cancer Center (Other); collaborators: Hospital for Special Surgery, New York, Weill Medical College of Cornell University, Columbia University, Rockefeller University
Conditions	Osteosarcoma
Interventions	Tissue Procurement (Other)
Dates	start 1997-08-01, primary completion 2027-08-01 (estimated), completion 2027-08-01 (estimated), first posted 2007-12-24, last updated 2026-05-01
Locations	1 site in United States

-Summary

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.

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+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 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.

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Other: Tissue Procurement

Tissue Procurement (Other): MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting

+Outcome measures

Primary outcomes

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. [2 years]

Secondary outcomes

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. [2 years]

+Eligibility

Sex: All

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:

* N/A

+Locations (1)

Facility	City	Country	Status
Memorial Sloan Kettering Cancer Center	New York, New York	United States

+Investigators

Carol Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center

My Notes

Public

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