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Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Primary Purpose

Osteosarcoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tissue Procurement

About this trial

This is an interventional diagnostic trial for Osteosarcoma focused on measuring BONE

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

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.

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.

Full Information

NCT ID

NCT00580385

First Posted

December 20, 2007

Last Updated

September 1, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Hospital for Special Surgery, New York, Weill Medical College of Cornell University, Columbia University, Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT00580385

Brief Title

Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Official Title

Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1997 (undefined)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Hospital for Special Surgery, New York, Weill Medical College of Cornell University, Columbia University, Rockefeller University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteosarcoma

Keywords

BONE

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

763 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Tissue Procurement

Intervention Description

MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Healey, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors

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