Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: monoclonal antibody huJ591 |
Phase 2 |
| Study Type: | Interventional |
| 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 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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 weeks apart
- 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
- Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy
- 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:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- 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
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No clinically significant cardiac disease (New York Heart Association class III or IV)
Pulmonary:
- No severe debilitating pulmonary disease
Other:
- Fertile patients must use effective contraception
- No active uncontrolled infection or infection requiring IV antibiotics
- No prior autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior murine protein for diagnostic or therapeutic purposes
- No other concurrent anticancer immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent anticancer chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No concurrent anticancer hormonal therapy
Radiotherapy:
- 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
Surgery:
- See Disease Characteristics
- No concurrent surgery
Other:
- 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 experimental drug
- 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 drug
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024232 History of Changes |
| Other Study ID Numbers: | CDR0000068903, MSKCC-01030, NCI-G01-2013 |
| Study First Received: | September 13, 2001 |
| Last Updated: | June 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013