Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2

Prostatic Neoplasms Clinical Trial

Official title:

Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040586
• Other study ID #: 1100-471
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2002
• Last updated: January 19, 2007

Study information

• Verified date: July 2002
• Source: BZL Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.

Description:

In this Phase II, open label study, patients will receive daily low-dose subcutaneous rIL-2 (1.2 x 10^6 IU/m^2/day) continuously beginning on day 1. Patients will receive 3 weeks of IL-2, and on day 22 will receive the monoclonal antibody huJ591 via I.V. (25mg/m^2) for 3 consecutive weeks. Il-2 will be continued for 2 additional weeks for a total of 8 weeks. The 8 week regimen will constitute 1 cycle of therapy. Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Eligibility Criteria:

• Histologic diagnosis (recent or remote) of prostate adenocarcinoma

• Metastatic or recurrent carcinoma of the prostate defined by abnormal CT or MRI and/or abnormal bone scan and/or rising PSA.

• Rising PSA on 3 serial determinations over a period of > or equal to 2 weeks.

• PSA > or equal to 1.0 at the time of entry.

• If patient is being treated with an LHRH analog the drug: a. must be maintained for the duration of the study or b. must be terminated > or equal to 10 weeks prior to entry (for 28 day depot preparations) or 24 weeks (for 3 month depot preparations).

Exclusion Criteria:

• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry.

• History of CNS metastasis, and/or history of seizure and/or stroke.

• Lab values: ANC<1500/mm3; platelet count<100,000/mm3; serum creatinine>2.0; SGOT>2 x normal; bilirubin (total)>1.5; serum calcium> or equal to 11.5.

• Active serious infection not controlled by antibiotics.

• Active angina pectoris or NYHA Class III-IV.

• Karnofsky Performance Status <60.

• Life Expectancy < 3 months.

• Age< 21y.

• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

• Untreated thyroid disease, with the exception of treated and stable hyperthyroidism or hypothyroidism for at least 4 weeks prior to entry.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Monoclonal Antibody J591

• Recombinant Interleukin-2

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital Medical Oncology/Urology Clinics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BZL Biologics

Country where clinical trial is conducted

United States,