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

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ClinicalTrials.gov Identifier: NCT00132704
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ovarian Neoplasms Colorectal Neoplasms Melanoma Small Cell Lung Cancer Liposarcoma Radiation: Ionizing radiation (IR) therapy Radiation: Ionizing radiation (IR)

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.

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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Study Start Date : August 2004
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


Group/Cohort Intervention/treatment
A
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.
Radiation: Ionizing radiation (IR) therapy
Tumors will be sliced into 0.5cm fragments, incubated in culture medium and then irradiated to evaluate the kinetics and dose-dependencies of the endothelial apoptotic response. We will irradiate tumor fragments ex vivo at 0, 7, 13, 15, 17, and 25 Gy.

B
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.
Radiation: Ionizing radiation (IR)
Tissue fragments of a total quantity of at least a 4x4x4 cm3 will be required. For each tumor a paraffin block will also be made for routine staining and IHC. Endothelial cell populations (at least 500 cells) will then be exposed to radiation at 0, 7, 11, 13, 15, 17, and 25 Gy and harvested at 4, 5 and 8 hours post IR.




Primary Outcome Measures :
  1. apoptotic response [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
tissue


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132704


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Zelefsky, M.D. Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00132704    
Other Study ID Numbers: 04-109
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Neoplasms
Melanoma
Small Cell Lung Carcinoma
Colorectal Neoplasms
Ovarian Neoplasms
Liposarcoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases