- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132704
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
apoptotic response
Time Frame: 2 years
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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).
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2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Zelefsky, M.D., Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Neuroendocrine Tumors
- Nevi and Melanomas
- Sarcoma
- Neoplasms, Adipose Tissue
- Neoplasms
- Colorectal Neoplasms
- Ovarian Neoplasms
- Small Cell Lung Carcinoma
- Melanoma
- Liposarcoma
Other Study ID Numbers
- 04-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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