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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00132704 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms Colorectal Neoplasms Melanoma Small Cell Lung Cancer Liposarcoma |
Radiation: Ionizing radiation (IR) therapy Radiation: Ionizing radiation (IR) |
Phase III |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation |
tissue
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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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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.
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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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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.
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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:
Secondary Outcomes:
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
undergoing surgery on the Neurosurgery, Hepatobiliary, Colorectal, Urology, Head and Neck, Gynecology, GMT and Thoracic Services at Memorial Sloan- Kettering Cancer Center.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Zelefsky, M.D. | 212-639-6802 | zelefskm@mskcc.org |
| Contact: James Eastham, MD | easthamj@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Michael Zelefsky, M.D. | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan Kettering Cancer Center ( Michael Zelefsky, MD ) |
| Study ID Numbers: | 04-109 |
| Study First Received: | August 18, 2005 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00132704 |
| Health Authority: | United States: Institutional Review Board |
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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 |
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Thoracic Neoplasms Pancreatic Neoplasms Malignant mesenchymal tumor Colonic Diseases Urogenital Neoplasms Carcinoma, Endometrioid Rectal Diseases Neoplasms, Connective and Soft Tissue Lung Neoplasms Neoplasm Metastasis Neuroepithelioma Glioma Endocrine Gland Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Breast Neoplasms Endocrine System Diseases Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Liposarcoma Lung Diseases Sarcoma Gastrointestinal Neoplasms Nevus Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Cystadenocarcinoma, Serous Carcinoma, Neuroendocrine Gastrointestinal Diseases |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Nerve Tissue Nevi and Melanomas Adnexal Diseases Neoplasms, Adipose Tissue |
