Clinical trial NCT00132704: An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Official title: An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Colorectal Neoplasms
Melanoma
Small Cell Lung Cancer
Liposarcoma
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-08-22
Enrollment: 149
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: undergoing surgery on the Neurosurgery, Hepatobiliary, Colorectal, Urology, Head and Neck, Gynecology, GMT and Thoracic Services at 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.

Eligibility criteria: 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

Primary outcomes:
measure: apoptotic response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Zelefsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: