Clinical trial · Interventional
Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer
Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| IL2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- I
- description
- Docetaxel followed by IL-2
- interventionNames
- Drug: docetaxel
- Drug: IL2
Primary outcomes (1)
- 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.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To determine the impact of docetaxel on the natural immune defense system in patients before IL-2 administration.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available