Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Not Applicable

Active, not recruiting

• Conditions: Osteosarcoma
• Interventions: Other: Tissue Procurement

• Registration Number: NCT00580385
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1997-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 763

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

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tissue Procurement	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States