NCT00040586

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2002

Completed
Last Updated

January 22, 2007

Status Verified

July 1, 2002

First QC Date

July 1, 2002

Last Update Submit

January 19, 2007

Conditions

Prostatic Neoplasms

Keywords

hormone-refractory

Interventions

Monoclonal Antibody J591DRUG
Recombinant Interleukin-2DRUG

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital Medical Oncology/Urology Clinics

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

J591 monoclonal antibodyInterleukin-2

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 1, 2002

First Posted

July 2, 2002

Last Updated

January 22, 2007

Record last verified: 2002-07

Locations

US(1)