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

This study has been completed.
Sponsor:
Information provided by:
BZL Biologics
ClinicalTrials.gov Identifier:
NCT00040586
First received: July 1, 2002
Last updated: January 19, 2007
Last verified: July 2002
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Monoclonal Antibody J591
Drug: Recombinant Interleukin-2
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by BZL Biologics:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040586

Locations
United States, New York
New York Presbyterian Hospital Medical Oncology/Urology Clinics
New York, New York, United States, 10021
Sponsors and Collaborators
BZL Biologics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040586     History of Changes
Other Study ID Numbers: 1100-471
Study First Received: July 1, 2002
Last Updated: January 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by BZL Biologics:
hormone-refractory

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014