RATIONALE: Biological therapies such as APC8015F work in different ways to stimulate the immune system and stop tumor cells from growing.

PURPOSE: This phase II trial is studying how well APC8015F works in treating patients with progressive metastatic prostate cancer and disease-related pain.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer	Drug: APC8015F  Drug: prostatic acid phosphatase-sargramostim fusion protein  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: in vitro-treated peripheral blood stem cell transplantation  Procedure: leukocyte therapy  Procedure: peripheral blood lymphocyte therapy  Procedure: targeted fusion protein therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the safety of APC8015F in patients with metastatic prostate cancer who had objective disease progression and disease-related pain while enrolled on the control arm of .

Secondary

• Determine the efficacy of this drug, in terms of prostate-specific antigen doubling time, in these patients.
• Determine overall clinical response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive APC8015F comprising autologous antigen-presenting cell precursors activated with prostatic acid phosphatase-sargramostin fusion protein IV over 30-60 minutes on day 1 of weeks 0, 2, and 4 (total of 3 infusions) in the absence of unacceptable toxicity.

Patients are followed at 4, 12, and 20 weeks after completion of study treatment.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Androgen-independent disease
• Soft tissue and/or bony metastatic disease on imaging studies
• Gleason score ≤ 7
• Must have been enrolled on the control (placebo) arm of
• Confirmation of objective disease progression and disease-related pain while on study

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 24 weeks

Hematopoietic

• WBC ≥ 2,000/mm^3
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 2.0 mg/dL

Other

• Fertile patients must use effective contraception
• No infection within the past week
• No unexplained fever (temperature > 100.5°F or 38.1°C) within the past week
• No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• More than 2 weeks since prior megestrol or diethylstilbestrol
• More than 2 weeks since prior systemic corticosteroids
• Concurrent inhaled, intranasal, or topical steroids allowed
• More than 2 weeks since prior 5-α-reductase inhibitors (e.g., finasteride)
• Concurrent luteinizing hormone-releasing hormone agonists or other medical castration therapy allowed

Radiotherapy

• More than 2 weeks since prior external beam radiotherapy

Surgery

• More than 2 weeks since prior surgery

Other

• More than 1 week since prior antibiotics
• More than 2 weeks since other prior systemic therapy for prostate cancer
• More than 2 weeks since prior treatment with any of the following:
• High-dose calcitriol
• Saw palmetto
• PC-SPES
• Ketoconazole
• No initiation or discontinuation of bisphosphonates within the past 2 weeks
• Concurrent bisphosphonates allowed provided dose is stable

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1738,  United States; Recruiting

Study chairs or principal investigators

Allan Pantuck, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000380847; UCLA-0307122-01; DEN-PB01; NCT00090922
Record last reviewed:  August 2004
Last Updated:  March 10, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090922
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08