Prostate CancerPhase 1/2NCT00283829
Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer
A Phase 1/2 study testing docetaxel and IL2 in people with Prostate Cancer, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and IL2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jul 2006
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are age >18 years with histological diagnosis of prostate cancer
- Hormone refractory disease with at least 2 serial rises in PSA with a castrate level of testosterone (< 50ng/dL). Primary hormonal therapy will be continued.
- Patients must have metastatic disease as evidenced by soft tissue or bony metastasis
- Patients have an ECOG performance status of 0, 1, 2
- Patients must have preserved organ function
- Bilirubin < ULN and serum creatinine 1.5 x ULN, transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are ULN.
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- Patients must be off chronic steroid treatment for at least 2 weeks, and pre-/post-chemotherapy steroid medication for at least 1 week
- Patients may not receive Taxanes previously.
- Patients must be able to complete pain and quality of life scales.
- Ancillary treatments, such as bisphosphonate, pain medication is allowed, but natural herbal, homeopathic supplements such as MGN-3 is not allowed.
- Absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelet count > 100,000/mm3.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a 12 month period thereafter.
Who cannot join
- Patients on chronic steroid medication
- Spine radiation therapy for cord compression within 2 weeks of study entry
- Concurrent use of other investigational therapy
- Prior immunotherapy with IL2 or alpha-interferon within 30 days
- Peripheral neuropathy > Grade 1
- Other active malignancy, except non-melanotic skin cancer
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- Significant active medical illness or psychosocial condition that in the opinion of the investigator would preclude protocol treatment.
- Hypersensitivity to drugs formulated with polysorbate-80
- Patients with contraindications to Coumadin or aspirin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, IL2
- Keywords
- Immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called taxotere
chemotherapy
IL2Drug
Also called Interleukin
immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| I | Other | Docetaxel followed by IL-2 Receives: Drug: docetaxel; Drug: IL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of sequencing low dose SQ IL-2 with chemotherapy in patients with hormone refractory prostate cancer (HRPC) in an outpatient setting.
Measured: 2 years
Secondary outcomes (1)
To determine the impact of docetaxel on the natural immune defense system in patients before IL-2 administration.
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 posted30 Jan 2006 (estimated)
- Study startSep 2002
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Celestia Higano, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283829
- Sponsor's protocol ID
- 02-3017-A-04
- Other IDs
- IIT-16117, USI-IL2-01-012
- Status last verified
- Nov 2007
- First submitted
- 26 Jan 2006
- Last updated
- 29 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study
- ClinicalTrials.gov ID
- NCT00283829
- Acronym / sponsor ID
- 02-3017-A-04
- Conditions
- Prostate Cancer
- Keywords
- Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Sep 2002
- Study completion
- Jul 2006 (actual)
- First posted
- 30 Jan 2006 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Other | Drug: docetaxel, Drug: IL2Docetaxel followed by IL-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients are age >18 years with histological diagnosis of prostate cancer
- Hormone refractory disease with at least 2 serial rises in PSA with a castrate level of testosterone (< 50ng/dL). Primary hormonal therapy will be continued.
- Patients must have metastatic disease as evidenced by soft tissue or bony metastasis
- Patients have an ECOG performance status of 0, 1, 2
- Patients must have preserved organ function
Key exclusion criteria (9 listed)
- Patients on chronic steroid medication
- Spine radiation therapy for cord compression within 2 weeks of study entry
- Concurrent use of other investigational therapy
- Prior immunotherapy with IL2 or alpha-interferon within 30 days
- Peripheral neuropathy > Grade 1
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 |
|---|---|---|
| docetaxelAlso: taxoterechemotherapy | Drug | I |
| IL2Also: Interleukinimmunotherapy | Drug | I |
Primary outcome
To determine the feasibility of sequencing low dose SQ IL-2 with chemotherapy in patients with hormone refractory prostate cancer (HRPC) in an outpatient setting.
Time frame: 2 years
1 secondary outcome
To determine the impact of docetaxel on the natural immune defense system in patients before IL-2 administration.
Time frame: 2 years
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 29 Nov 2007.
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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.
Celestia Higano, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel and IL2 in people with Prostate Cancer, run by University of Washington 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 12 inclusion and 9 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 29 Nov 2007. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the feasibility of sequencing low dose SQ IL-2 with chemotherapy in patients with hormone refractory prostate cancer (HRPC) in an outpatient setting. (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 29 Nov 2007; AzTrials last refreshed its copy on 7 Nov 2026.