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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Monoclonal Antibody J591
Recombinant Interleukin-2
Sponsored by
BZL Biologics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring hormone-refractory

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Presbyterian Hospital Medical Oncology/Urology Clinics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 1, 2002
Last Updated
January 19, 2007
Sponsor
BZL Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00040586
Brief Title
Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2
Official Title
Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
BZL Biologics

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
hormone-refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Monoclonal Antibody J591
Intervention Type
Drug
Intervention Name(s)
Recombinant Interleukin-2

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
New York Presbyterian Hospital Medical Oncology/Urology Clinics
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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