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.

Date First Received: August 18, 2005

Last Updated: November 29, 2007

Verified by: Memorial Sloan-Kettering Cancer Center, November 2007

Clinical Trial Phase: Phase 3 Start Date: August 2004

Overall Status: Recruiting

Estimated Enrollment: 150

Brief Summary

Official Title: “An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation”

Condition Keyword(s):

• Ovarian Neoplasms
• Colorectal Neoplasms
• Melanoma
• Small Cell Lung Cancer
• Liposarcoma

Intervention(s):

• Radiation: Ionizing radiation (IR) therapy
• Radiation: Ionizing radiation (IR)

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.

Study Type: Observational

Study Design: Cohort, Prospective

Detailed Clinical Trial 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.

Criteria for Participation in this Clinical Trial

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

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center

New York New York 10021 United States

Overall Clinical Trial Officials and Contacts

Michael Zelefsky, M.D. Principal Investigator Memorial Sloan-Kettering Cancer Center
Overall Contact: Michael Zelefsky, M.D. 212-639-6802
zelefskm@mskcc.org

Additional Information
Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record.
http://clinicaltrials.gov/show/NCT00132704
Study ID Number: 04-109

ClinicalTrials.gov Identifier: NCT00132704

Health Authority: United States: Institutional Review Board
(Memorial Sloan-Kettering Cancer Center)
Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial