An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation

Completed

• Conditions: Small Cell Lung Cancer; Liposarcoma; Melanoma; Colorectal Neoplasms; Ovarian Neoplasms
• Interventions: Radiation: Ionizing radiation (IR); Radiation: Ionizing radiation (IR) therapy

• Registration Number: NCT00132704
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Doctors will take some tissue from the tissue removed during surgery in order to study how the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used to determine how these tumor blood vessels respond to radiation therapy delivered to the tumor, after it has been removed. This radiation is delivered in the research lab. This research is being conducted in order to develop new methods to treat tumors by radiation therapy. No additional surgery will be performed to obtain these samples, and only materials that remain after all diagnostic testing has been completed will be used.

Detailed Description

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.

Primary Outcomes:

* To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.

Secondary Outcomes:

* 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Patients who are felt to have adequate tumor volume for these studies, at least a 2 x 2 x 2 cm3 tumor by physical exam, imaging studies or colonoscopy reports
• Primary or recurrent tumors are eligible
• Patients must be suitable candidates for surgery
• Patients who have signed the informed consent

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Exclusion Criteria

• Patients who are not considered suitable candidates for surgery
• Patients who have received prior radiation therapy to the tumor being removed
• Patients who have received chemotherapy within 6 months of tumor removal
• Patients who are pregnant
• Patients may choose to be excluded at any time
• Minors are excluded from this study because there are expected to be very few minors with the tumor types which the investigators are evaluating in this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Ionizing radiation (IR)	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.
A	Ionizing radiation (IR) therapy	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.

Primary Outcome Measures

Name	Time	Method
apoptotic response	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).

Trial Locations

Locations (1)

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