Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Sanofi
• Treatments: Docetaxel; Hormones

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.