Status:
COMPLETED
Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 b...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00283829
Start Date
September 1 2002
End Date
July 1 2006
Last Update
November 29 2007
Active Locations (1)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109