RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in
treating patients who have prostate cancer that has not responded to hormone therapy.
- Determine the antitumor effects of monoclonal antibody huJ591 in patients with
progressive androgen-independent prostate cancer.
- Determine the biodistribution and dosimetry of this antibody in these patients.
- Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium
In 111-labeled antibody in these patients.
- Determine the HAHA response in patients treated with this regimen.
- Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular
cytotoxicity in these patients.
OUTLINE: Patients are assigned to one of two treatment groups.
- Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111
monoclonal antibody huJ591 on day 1.
- Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111
monoclonal antibody huJ591 as in group I.
Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed for 4 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) will be accrued for this
- Histologically confirmed prostate cancer
- Disease progression after prior castration
- At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4
- New osseous lesions on bone scan and/or more than 25% increase in bidimensionally
measurable soft tissue disease or appearance of new sites of disease by CT scan or
- Testosterone no greater than 50 ng/mL
- Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain
castrate level of testosterone should continue in the absence of surgical
- Progression of disease after discontinuation of prior anti-androgen therapy
- No requirement for palliative therapy within the past 12 weeks
- No active CNS or epidural primary tumor OR active CNS or epidural metastases
- 18 and over
- Karnofsky 60-100%
- Not specified
- WBC greater than 3,500/mm3
- Platelet count greater than 100,000/mm3
- Bilirubin less than 1.5 mg/dL
- Gamma-glutamyl-transferase less than upper limit of normal (ULN)
- AST less than ULN
- PT less than 14 seconds
- No prior autoimmune hepatitis
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No clinically significant cardiac disease (New York Heart Association class III or
- No severe debilitating pulmonary disease
- Fertile patients must use effective contraception
- No active uncontrolled infection or infection requiring IV antibiotics
- No prior autoimmune disease
PRIOR CONCURRENT THERAPY:
- No prior murine protein for diagnostic or therapeutic purposes
- No other concurrent anticancer immunotherapy
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent anticancer chemotherapy
- See Disease Characteristics
- No concurrent anticancer hormonal therapy
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the
site does not contain sole measurable lesion
- See Disease Characteristics
- No concurrent surgery
- Recovered from all prior therapy
- At least 4 weeks since prior therapeutic investigational anticancer drugs
- At least 4 weeks since prior participation in therapeutic clinical trial with an
- No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans
- No other concurrent therapeutic investigational anticancer agents
- No concurrent participation in other therapeutic clinical trial with an experimental