Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00024232|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: monoclonal antibody huJ591||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024232
|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|