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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068903 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-G01-2013 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: Patients are assigned to one of two treatment groups.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monoclonal antibody huJ591 | Biological |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Disease progression after prior castration
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 MRI
Testosterone no greater than 50 ng/mL
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Morris, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |