Ovarian NeoplasmsNCT00132704
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
An observational study of Ovarian Neoplasms and Colorectal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ovarian Neoplasms, Colorectal Neoplasms, Melanoma
- What is being tested?
- Ionizing radiation (IR) therapy and Ionizing radiation (IR)
- Type of treatment
- Surgery or procedure
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: undergoing surgery on the Neurosurgery, Hepatobiliary, Colorectal, Urology, Head and Neck, Gynecology, GMT and Thoracic Services at Memorial Sloan- Kettering Cancer Center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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.
- Being tested
- Ionizing radiation (IR) therapy, Ionizing radiation (IR)
- 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
- Medical subject headings
- Ovarian Neoplasms, Colorectal Neoplasms, Melanoma, Small Cell Lung Carcinoma, Liposarcoma, Adenocarcinoma, Carcinoma, Ductal, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ionizing radiation (IR) therapyRadiation
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.
Ionizing radiation (IR)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Ionizing radiation (IR) therapy | |
| 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. Receives: Radiation: Ionizing radiation (IR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
apoptotic response
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132704
- Sponsor's protocol ID
- 04-109
- Status last verified
- Jul 2014
- First submitted
- 18 Aug 2005
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
- ClinicalTrials.gov ID
- NCT00132704
- Acronym / sponsor ID
- 04-109
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Radiation: Ionizing radiation (IR) therapyThe 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. |
| B | – | Radiation: Ionizing radiation (IR)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- undergoing surgery on the Neurosurgery, Hepatobiliary, Colorectal, Urology, Head and Neck, Gynecology, GMT and Thoracic Services at Memorial Sloan- Kettering Cancer Center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ionizing radiation (IR) therapyTumors 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. | Radiation | A |
| 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. | Radiation | B |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- (Memorial Sloan-Kettering Cancer Center)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zelefsky, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Colorectal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apoptotic response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.