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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00024232
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-06-30
Completion date
2004-02-29
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer, recurrent prostate cancer

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALmonoclonal antibody huJ591

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026