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

Phase 3
19 Years
Open (Enrolling)
Ovarian Neoplasms, Colorectal Neoplasms, Melanoma, Small Cell Lung Cancer, Liposarcoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Michael Zelefsky, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2004

Completion Date:

August 2013

Related Keywords:

  • Ovarian Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Small Cell Lung Cancer
  • Liposarcoma
  • Lung cancer metastases to the CNS (adenocarcinomas)
  • Melanoma metastases to the CNS
  • Breast cancer metastases to the CNS (ductal carcinomas)
  • Central nervous system gliomas
  • Colorectal cancers (adenocarcinomas)
  • Ovarian cancers (papillary serous carcinomas)
  • Endometrial cancers (endometrioid carcinomas)
  • Cervical cancers (squamous cell carcinomas)
  • Sarcomas (liposarcomas and leiomyosarcomas)
  • Thoracic mesotheliomas
  • Colorectal cancers metastatic to the liver
  • Primary adenocarcinomas of the lung
  • Primary squamous cell carcinomas of the lung
  • Pancreatic Cancers-adenocarcinoma
  • Neoplasms
  • Colorectal Neoplasms
  • Liposarcoma
  • Lung Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • Small Cell Lung Carcinoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021