Biological Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed Description
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OBJECTIVES: Determine the safety of activated autologous T cells (Xcellerate) therapy in patients with hormone-refractory prostate cancer. Determine the change in prostate-specific antigen (PSA) levels in patients treated with this therapy. Determine the effects on bone in patients treated with this therapy. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC). PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads (Xcellerate). Xcellerate-activated T cells are reinfused on day 0. Patients are followed weekly for 4 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Official Title
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A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: therapeutic autologous lymphocytes


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Evidence of androgen-independent disease Patient must have received prior primary hormonal therapy (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without antiandrogen) Demonstrated disease progression by any 1 of the following: Elevated PSA level (at least 5 ng/mL) that has serially risen from baseline on 2 occasions at least 1 week apart At least 1 new osseous lesion on bone scan More than 25% increase in the sum of the products of the perpendicular diameters of all bidimensionally measurable sites of disease No CNS metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGPT no greater than 1.5 times ULN Hepatitis B surface antigen negative No active or chronic hepatitis B or C No other hepatic dysfunction that would preclude study Renal: Creatinine less than 2.0 mg/dL Calcium less than 11 mg/dL No renal dysfunction that would preclude study No symptomatic hypercalcemia Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No pulmonary disease requiring inhaled steroids or bronchodilators Other: No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2 No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis) No other major organ system dysfunction No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study Human anti-mouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors, interleukin, interferons, or cytokines Chemotherapy: No prior chemotherapy or other systemic chemotherapy agent for prostate or any other cancer Endocrine therapy: Prior aminoglutethimide allowed At least 4 weeks since prior flutamide At least 6 weeks since prior bicalutamide or nilutamide Concurrent luteinizing hormone-releasing hormone agonists should be continued No concurrent corticosteroids or dexamethasone No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide) Radiotherapy: At least 4 weeks since prior local radiotherapy No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) No concurrent radiotherapy Surgery: Not specified Other: Prior ketoconazole or PC-SPES allowed At least 1 week since prior antibiotic, antifungal, or antiviral agents At least 4 weeks since other prior systemic therapy for prostate cancer (except bisphosphonates or hormonal therapy) At least 6 weeks since prior investigational drugs or devices No other concurrent therapy for this disease No concurrent participation in another clinical trial No concurrent bisphosphonates unless initiated prior to study No concurrent immunosuppressive drugs No other concurrent experimental therapies
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic autologous lymphocytes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer