Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283829
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2006-01-26
Brief Title:
Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer A Phase III Study
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test if interleukin-2 a drug that stimulates the immune system can be used after chemotherapy to slow the progression of your disease We also want to test what the best dose of interleukin-2 is that can be used safely at home
Interleukin-2 abbreviated as IL2 is a naturally produced growth hormone for the immune cells in our body It stimulates the growth of the immune cells and enhances their ability to fight infections and cancers In people with cancer the immune cells are typically suppressed and became even more so after irradiation and chemotherapy treatment By giving you more IL2 we hope to enhance the immune system so that it can fight the cancer better control cancer growth and shrink the cancer
Interleukin-2 abbreviated as IL2 is a naturally produced growth hormone for the immune cells in our body It stimulates the growth of the immune cells and enhances their ability to fight infections and cancers In people with cancer the immune cells are typically suppressed and became even more so after irradiation and chemotherapy treatment By giving you more IL2 we hope to enhance the immune system so that it can fight the cancer better control cancer growth and shrink the cancer
Detailed Description:
There are two treatment phases in this study But before you begin in the study we will need to find out whether you are eligible for the study You will undergo the following procedures
Medical history review and physical exam
Blood tests for hematology chemistries PSA and immune assays approximately 4 tablespoons of blood
EKG
CT scan of the abdomen and pelvis and a bone scan
Complete a pain questionnaire quality of life questionnaire pain medication diary and symptom diary
The initial treatment phase of this study consists of chemotherapy drug given weekly You will receive 3 weekly chemotherapy treatments followed by 1 week with no treatment Three weeks of treatment followed by one week of no treatment is considered 1 cycle and you will receive a total of 4 cycles of chemotherapy over a 16-week period Taxotere is given intravenously in the clinic on the 1st day of each weekly treatment
Treatment with taxotere is a currently accepted treatment for this stage prostate cancer Your doctor may recommend you receive taxotere even if you do not participate in this study During this phase of treatment you will have blood draws on treatment weeks prior to having the chemotherapy You will have a PSA drawn every month weeks 5 9 and 13 We will ask you to complete a pain questionnaire quality of life questionnaire pain medication diary and symptom diary at weeks 5 9 and 13 Some of the questions may be personal such as I am satisfied with my sex life and I worry about dying You do not have to answer these questions if you do not want to You will also have a physical exam at the beginning of your 3rd cycle of treatment week 9
The second phase of the treatment program is the experimental part immunotherapy with IL2 You will be assigned to receive one of 4 doses of IL2 This is because we are testing what is the highest dose of IL2 that a subject can receive without having unacceptable side affects from the IL2 You will give yourself shots of IL2 under the skin twice a day for 5 days per week for 3 weeks During the 3rd week of treatment there are 2 days when you have to give a higher dose of IL2 for boosting the immune cells see below diagram The 4th week will be a rest week where you do not receive treatment One 4-week period of IL2 treatment is called a cycle You will continue to receive cycles of IL2 treatment as long as your cancer shows no further growth We will teach you how to administer the IL2 at home
Medical history review and physical exam
Blood tests for hematology chemistries PSA and immune assays approximately 4 tablespoons of blood
EKG
CT scan of the abdomen and pelvis and a bone scan
Complete a pain questionnaire quality of life questionnaire pain medication diary and symptom diary
The initial treatment phase of this study consists of chemotherapy drug given weekly You will receive 3 weekly chemotherapy treatments followed by 1 week with no treatment Three weeks of treatment followed by one week of no treatment is considered 1 cycle and you will receive a total of 4 cycles of chemotherapy over a 16-week period Taxotere is given intravenously in the clinic on the 1st day of each weekly treatment
Treatment with taxotere is a currently accepted treatment for this stage prostate cancer Your doctor may recommend you receive taxotere even if you do not participate in this study During this phase of treatment you will have blood draws on treatment weeks prior to having the chemotherapy You will have a PSA drawn every month weeks 5 9 and 13 We will ask you to complete a pain questionnaire quality of life questionnaire pain medication diary and symptom diary at weeks 5 9 and 13 Some of the questions may be personal such as I am satisfied with my sex life and I worry about dying You do not have to answer these questions if you do not want to You will also have a physical exam at the beginning of your 3rd cycle of treatment week 9
The second phase of the treatment program is the experimental part immunotherapy with IL2 You will be assigned to receive one of 4 doses of IL2 This is because we are testing what is the highest dose of IL2 that a subject can receive without having unacceptable side affects from the IL2 You will give yourself shots of IL2 under the skin twice a day for 5 days per week for 3 weeks During the 3rd week of treatment there are 2 days when you have to give a higher dose of IL2 for boosting the immune cells see below diagram The 4th week will be a rest week where you do not receive treatment One 4-week period of IL2 treatment is called a cycle You will continue to receive cycles of IL2 treatment as long as your cancer shows no further growth We will teach you how to administer the IL2 at home
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 |
|---|---|---|---|
| USI-IL2-01-012 | None | None | None |
| IIT-16117 | None | None | None |