Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer|
|Study Start Date:||June 2001|
|Study Completion Date:||February 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- 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 study.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Michael Morris, MD||Memorial Sloan-Kettering Cancer Center|