Clinical trial NCT00580385: Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors
Official title: Chemotherapy Resistance in Osteogenic Sarcoma and Other Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteosarcoma
Keywords: BONE
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Hospital for Special Surgery, New York
name: Weill Medical College of Cornell University
name: Columbia University
name: Rockefeller University
First posted: 2007-12-24
Enrollment: 763
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Healey, MD
role: PRINCIPAL_INVESTIGATOR
References: