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An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
This study is ongoing, but not recruiting participants.
Study NCT00132704   Information provided by Memorial Sloan-Kettering Cancer Center
First Received: August 18, 2005   Last Updated: August 14, 2009   History of Changes

August 18, 2005
August 14, 2009
August 2004
August 2010   (final data collection date for primary outcome measure)
 
To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.
Complete list of historical versions of study NCT00132704 on ClinicalTrials.gov Archive Site
 
  • 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.
 
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation

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.

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.
Phase III
Observational
Cohort, Prospective
  • Ovarian Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Small Cell Lung Cancer
  • Liposarcoma
  • Radiation: Ionizing radiation (IR) therapy
  • Radiation: Ionizing radiation (IR)
  • 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.
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
149
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00132704
Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Center
04-109
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Michael Zelefsky, M.D. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP