Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

NCT00024232 | Completed Phase 2

• 3 other identifiers: MSKCC-01030CDR0000068903NCI-G01-2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Interventions

monoclonal antibody huJ591 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Morris, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)