An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
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|ClinicalTrials.gov Identifier: NCT00132704|
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : July 24, 2014
|Condition or disease||Intervention/treatment|
|Ovarian Neoplasms Colorectal Neoplasms Melanoma Small Cell Lung Cancer Liposarcoma||Radiation: Ionizing radiation (IR) therapy Radiation: Ionizing radiation (IR)|
The goal of this study is to determine if concepts established in mouse models of the tumor microvascular response to ionizing radiation (IR) therapy are applicable to human tumors in order to begin to establish that the engagement of the endothelial response is a valid target for IR in human tumors. A portion of tumor will be isolated from individuals who have signed informed consent for this protocol and are undergoing surgery on the Neurosurgery, Colorectal, and Gynecology, Head and Neck, Urology, and Hepatobiliary Services at Memorial Sloan-Kettering Cancer Center. Tumor tissue will be obtained from the surgical sample in pathology after adequate specimens have been obtained for diagnostic purposes. Tumor tissue will be irradiated ex vivo and the microvascular endothelial response will be determined. From specimens of adequate size, a pure tumor endothelial cell population will be isolated and the response to IR will be determined.
- To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.
- To determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.
- To determine if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
The experiments in Group A will be conducted in order to determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium, and if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.
Radiation: Ionizing radiation (IR) therapy
Tumors will be sliced into 0.5cm fragments, incubated in culture medium and then irradiated to evaluate the kinetics and dose-dependencies of the endothelial apoptotic response. We will irradiate tumor fragments ex vivo at 0, 7, 13, 15, 17, and 25 Gy.
The experiments in Group B will be conducted in order to determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.
Radiation: Ionizing radiation (IR)
Tissue fragments of a total quantity of at least a 4x4x4 cm3 will be required. For each tumor a paraffin block will also be made for routine staining and IHC. Endothelial cell populations (at least 500 cells) will then be exposed to radiation at 0, 7, 11, 13, 15, 17, and 25 Gy and harvested at 4, 5 and 8 hours post IR.
- apoptotic response [ Time Frame: 2 years ]The peak apoptotic radiation response will be obtained for each of the tumor type and the result compared to that of the mouse experiments in Garcia-Barros (no formal testing only qualitative statements).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132704
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michael Zelefsky, M.D.||Memorial Sloan Kettering Cancer Center|