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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody muJ591
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate, defined by: Abnormal CT, MRI, or bone scan and/or Rising prostate specific antigen (PSA) levels (on 3 consecutive occasions over at least 6 weeks) despite hormonal therapy PSA at least 2.0 at study entry No active CNS metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 No serious hematologic disease Hepatic: SGOT less than 2.0 times upper limit of normal Bilirubin less than 1.5 mg/dL No serious hepatic disease Renal: Creatinine less than 2.0 mg/dL Calcium less than 13.5 mg/dL No serious renal disease Cardiovascular: No active angina No New York Heart Association class III-IV No other serious cardiac disease Pulmonary: No serious respiratory disease Other: No active uncontrolled infection Evidence of pre-existing antimouse antibody at the time of screening PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 6 weeks since prior adrenal hormone inhibitors or corticosteroid therapy Antiandrogen therapy must be discontinued prior to measuring PSA values Luteinizing hormone-releasing hormone analog must be maintained during study OR must be discontinued at least 10 weeks prior to study entry (for 28 day depot preparation) or 24 weeks prior to study entry (for 3 month depot preparation) Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: Not specified

Sites / Locations

  • New York Presbyterian Hospital - Cornell Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 9, 2009
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00003391
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
Phase I Trial of Monoclonal Antibody muJ591 in Patients With Hormone-Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

5. Study Description

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 I trial to study the effectiveness of muJ591 monoclonal antibody in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: I. Define the toxicity and maximum tolerated dose of monoclonal antibody muJ591 in patients with hormone independent prostate cancer. II. Define the pharmacokinetics and biodistribution of monoclonal antibody muJ591 in these patients. III. Define the human antimouse antibody response to this therapy. IV. Define the preliminary efficacy of this therapy in these patients. OUTLINE: This is a dose escalation study. Patients receive a single dose of intravenous iodine I 131-labeled monoclonal antibody muJ591 on day 0, combined with an unlabeled (cold) dose of monoclonal antibody muJ591. Anterior and posterior imaging is obtained 1 hour after labeled muJ591 administration and on days 0, 2, 4, and 6. Subsequent cohorts of 3-6 patients receive fixed iodine-labeled doses with escalating cold doses of monoclonal antibody muJ591 until the maximum tolerated dose is reached. Patients are followed for a minimum of 8 weeks after muJ591 therapy or until disease progression. Patients with stable or responding disease who are human anti-mouse antibody negative may receive subsequent treatments at the discretion of the principal investigator. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody muJ591

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate, defined by: Abnormal CT, MRI, or bone scan and/or Rising prostate specific antigen (PSA) levels (on 3 consecutive occasions over at least 6 weeks) despite hormonal therapy PSA at least 2.0 at study entry No active CNS metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 No serious hematologic disease Hepatic: SGOT less than 2.0 times upper limit of normal Bilirubin less than 1.5 mg/dL No serious hepatic disease Renal: Creatinine less than 2.0 mg/dL Calcium less than 13.5 mg/dL No serious renal disease Cardiovascular: No active angina No New York Heart Association class III-IV No other serious cardiac disease Pulmonary: No serious respiratory disease Other: No active uncontrolled infection Evidence of pre-existing antimouse antibody at the time of screening PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 6 weeks since prior adrenal hormone inhibitors or corticosteroid therapy Antiandrogen therapy must be discontinued prior to measuring PSA values Luteinizing hormone-releasing hormone analog must be maintained during study OR must be discontinued at least 10 weeks prior to study entry (for 28 day depot preparation) or 24 weeks prior to study entry (for 3 month depot preparation) Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil H. Bander, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Chair
Facility Information:
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33465252
Citation
Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.
Results Reference
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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

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