Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176761
Status:
TERMINATED
Last Update Posted:
2006-09-11
First Post:
2005-09-09
Brief Title:
Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Phase II Trial Assessing Autologous Tumor-Pulsed Dendritic Cells as a Tumor Vaccine Administered With IL-2 in Patients With Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to determine the efficacy side effects and toxicity of an investigational vaccine that consists of tumor-pulsed dendritic cells administered with an immune stimulating drug called interleukin-2 IL-2 Dendritic cells are immune cells that are obtained from a subjects blood and are important in the bodys immune response to foreign substances This study will examine the response of a subjects immune system after receiving several vaccinations containing their own dendritic cells which have been exposed to dead fragments of their cancer cells in the laboratory This may result in sensitizing a subjects dendritic cells to their cancer cells so that their dendritic cells will react with other cells of the immune system and attack the cancer It has been shown in the laboratory that dendritic cells exposed to cancer cell fragments can provide lymphocytes a type of white blood cell with signals they require in order to become fully activated and acquire the ability to kill cancer cells
Detailed Description:
Pretreatment screening If a subject decides to participate in this study they will first be presented the informed consent document to read and review with the Principal Investigator or his designee to go over each aspect of the study and answer any questions Once the patient has consented they will first be screened to make sure they meet the eligibility criteria The screening process is done to make sure that it is appropriate for the subject to participate in this study This process will include a review of their medical history a complete physical examination standard blood tests an EKG an electrocardiogram a chest x-ray and if it is possible for them to become pregnant a pregnancy test These tests are normally performed on patients prior to receiving chemotherapy for cancer In addition to these tests which are normally performed blood will be obtained for tests which are specific for this investigational study
These study specific tests include a blood test to determine whether a subject may be infected with the hepatitis B virus or the AIDS virus and blood tests to determine the ability of their immune system to respond to normal stimulation A doctor will also order CT scans or nuclear medicine scans to measure the extent of the subjects cancer because the study therapy has a possibility of shrinking the tumor and this will be determined by measuring each subjects disease before and after therapy
At the time of this initial evaluation subjects will have skin tests that will determine their ability to mount an immune response to infectious agents such as tetanus measles mumps that they have been exposed to or vaccinated against If a subject fails to demonstrate a response to all the skin tests they will not be allowed to participate in this study because such lack of response indicates that their immune system may not respond to the therapy planned in this study
Vaccine therapy In order to make a vaccine from a subjects tumor they must have surgical removal of some tumor in order to provide tumor cells The doctor will determine if a subject has colorectal cancer cells that are easily obtainable However if a subject already has an available frozen tumor specimen at the University of Michigan that may be used for the vaccine preparation instead of undergoing another surgical procedure This surgery may be done solely for the purpose of participating in this research and may not otherwise benefit a subject A separate consent form will be required for any surgery a subject undergoes
The cancer cells obtained from each subject will be taken to the laboratory where they will be separated into single cells disrupted to make cell fragments radiated to kill the cells and then mixed with your dendritic cells The dendritic cells will be obtained from the peripheral blood Subjects will undergo a procedure called leukapheresis that involves placing a large needle central line in a vein in each of their arms These central lines will be inserted under local anesthesia subjects will remain awakeonly the site of the insertion will be frozen Blood exits from one needle and is processed through a machine that selectively removes one kind of white blood cell and then returns the other elements of the blood back to their body The leukapheresis procedure generally lasts three to four hours Following the procedure the dendritic cells will be cultured in the laboratory to increase the number of dendritic cells This procedure takes about 2 days
The tumor-exposed dendritic cell vaccine will be administered as an intradermal into the skin injection into a subjects thigh or arm on days 1 15 and 29 of study treatment Additionally they will receive IL-2 by subcutaneous injection daily for 4 days after each vaccination
Four weeks after their last vaccination subjects will undergo skin testing to determine if they are reactive to their tumor cells White blood cells will also be obtained by a second leukapheresis procedure to determine via research tests in the laboratory if their circulating immune cells have developed the capacity to respond to their cancer cells This skin testing and leukapheresis are for research purposes
Also 4 weeks after subjects receive their last vaccination they will have x-rays andor CT scans done to determine whether their disease has responded to the immune therapy If their cancer has not worsened or if it has shrunk then they will be offered the option to receive additional vaccinations using the tumor-pulsed dendritic cells providing that they did not experience severe toxicity with the first series of vaccinations and provided there is enough vaccine material available The additional vaccinations would be done using the same procedure and schedule as the previous vaccinations until there is evidence that the subjects disease has started to grow or worsen This includes leukapheresis vaccination and IL-2 administration Re-treatments will be offered until a subjects disease gets worse or tumor cells are no longer available to produce vaccines A subjects study participation will end with the leukopheresis and tumor evaluation 4 weeks following their last series of vaccinations
Blood Drawing The maximum amount of blood for standard tests and research purposes that will be drawn during the 10 weeks will be a total of 100ccs which is approximately 20 teaspoons which is equivalent to approximately 7 tablespoons over the 12 week time period
The length of time a subject would be on this study is a minimum of nine weeks If the physician determines that a subject is benefiting from this study they may continue repeat vaccinations for as long as they continue to have clinical benefit from the study and vaccine is available During the study if other therapy alternatives become clinically indicated they will be discussed with the subject Also if there are any significant new findings developed over the course of this research which may affect a subjects willingness to participate they will be told of them
These study specific tests include a blood test to determine whether a subject may be infected with the hepatitis B virus or the AIDS virus and blood tests to determine the ability of their immune system to respond to normal stimulation A doctor will also order CT scans or nuclear medicine scans to measure the extent of the subjects cancer because the study therapy has a possibility of shrinking the tumor and this will be determined by measuring each subjects disease before and after therapy
At the time of this initial evaluation subjects will have skin tests that will determine their ability to mount an immune response to infectious agents such as tetanus measles mumps that they have been exposed to or vaccinated against If a subject fails to demonstrate a response to all the skin tests they will not be allowed to participate in this study because such lack of response indicates that their immune system may not respond to the therapy planned in this study
Vaccine therapy In order to make a vaccine from a subjects tumor they must have surgical removal of some tumor in order to provide tumor cells The doctor will determine if a subject has colorectal cancer cells that are easily obtainable However if a subject already has an available frozen tumor specimen at the University of Michigan that may be used for the vaccine preparation instead of undergoing another surgical procedure This surgery may be done solely for the purpose of participating in this research and may not otherwise benefit a subject A separate consent form will be required for any surgery a subject undergoes
The cancer cells obtained from each subject will be taken to the laboratory where they will be separated into single cells disrupted to make cell fragments radiated to kill the cells and then mixed with your dendritic cells The dendritic cells will be obtained from the peripheral blood Subjects will undergo a procedure called leukapheresis that involves placing a large needle central line in a vein in each of their arms These central lines will be inserted under local anesthesia subjects will remain awakeonly the site of the insertion will be frozen Blood exits from one needle and is processed through a machine that selectively removes one kind of white blood cell and then returns the other elements of the blood back to their body The leukapheresis procedure generally lasts three to four hours Following the procedure the dendritic cells will be cultured in the laboratory to increase the number of dendritic cells This procedure takes about 2 days
The tumor-exposed dendritic cell vaccine will be administered as an intradermal into the skin injection into a subjects thigh or arm on days 1 15 and 29 of study treatment Additionally they will receive IL-2 by subcutaneous injection daily for 4 days after each vaccination
Four weeks after their last vaccination subjects will undergo skin testing to determine if they are reactive to their tumor cells White blood cells will also be obtained by a second leukapheresis procedure to determine via research tests in the laboratory if their circulating immune cells have developed the capacity to respond to their cancer cells This skin testing and leukapheresis are for research purposes
Also 4 weeks after subjects receive their last vaccination they will have x-rays andor CT scans done to determine whether their disease has responded to the immune therapy If their cancer has not worsened or if it has shrunk then they will be offered the option to receive additional vaccinations using the tumor-pulsed dendritic cells providing that they did not experience severe toxicity with the first series of vaccinations and provided there is enough vaccine material available The additional vaccinations would be done using the same procedure and schedule as the previous vaccinations until there is evidence that the subjects disease has started to grow or worsen This includes leukapheresis vaccination and IL-2 administration Re-treatments will be offered until a subjects disease gets worse or tumor cells are no longer available to produce vaccines A subjects study participation will end with the leukopheresis and tumor evaluation 4 weeks following their last series of vaccinations
Blood Drawing The maximum amount of blood for standard tests and research purposes that will be drawn during the 10 weeks will be a total of 100ccs which is approximately 20 teaspoons which is equivalent to approximately 7 tablespoons over the 12 week time period
The length of time a subject would be on this study is a minimum of nine weeks If the physician determines that a subject is benefiting from this study they may continue repeat vaccinations for as long as they continue to have clinical benefit from the study and vaccine is available During the study if other therapy alternatives become clinically indicated they will be discussed with the subject Also if there are any significant new findings developed over the course of this research which may affect a subjects willingness to participate they will be told of them
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCRC Protocol 1673 | None | None | None |