Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Immunotherapy
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Seattle Cancer Care Alliance
Arms of the Study
Arm 1
Other
I
Docetaxel followed by IL-2