Completed

A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+7

+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591. * Determine the measurable disease response rate in patients treated with this drug. Secondary * Determine the toxicity of this drug in these patients. * Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug. * Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug. * Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients. * Determine the survival rate in patients treated with this drug. * Determine the targeting of this drug to known tumor sites in these patients. * Determine the tumor-absorbed radiation dose in patients treated with this drug. OUTLINE: This is a multicenter, open-label study. Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1. Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study.

Official TitleA Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer 
NCT00081172
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Metastatic disease * Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters: * New osseous lesions on bone scan * Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan * Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy * Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement * PSA must be ≥ 5 ng/mL and ≥ 25% above the previous nadir * Measurable or evaluable disease * Serum testosterone ≤ 50 ng/dL * No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan") PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Hematocrit ≥ 30% * Hemoglobin ≥ 10 g/dL * Platelet count ≥ 150,000/mm\^3 * No serious hematologic illness that would preclude study participation Hepatic * AST ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * PTT normal * PT normal OR * INR normal * No serious hepatic illness that would preclude study participation Renal * Creatinine ≤ 2.5 mg/dL * Calcium ≤ 11 mg/dL * No serious renal illness that would preclude study participation Cardiovascular * No New York Heart Association class III or IV heart disease * No active angina pectoris * No prior deep vein thrombophlebitis within the past 3 months * No other serious cardiac illness that would preclude study participation Pulmonary * No pulmonary embolus within the past 3 months * No other serious respiratory illness that would preclude study participation Other * Fertile patients must use effective contraception * HIV negative * No serious CNS illness that would preclude study participation * No active serious infection not controlled by antibiotics * No other serious illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior red blood cell or platelet transfusions * More than 2 weeks since prior hematopoietic growth factors * No prior monoclonal antibody therapy except ProstaScint® * No other concurrent monoclonal antibody-based therapy * No concurrent medication to support platelet count (e.g., oprelvekin) Chemotherapy * More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true: * Treatment is maintained during study participation * Treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry * More than 4 weeks since prior corticosteroids * More than 4 weeks since prior adrenal hormone inhibitors * Concurrent low-dose prednisone (≤ 5mg/day) for adrenal insufficiency allowed * No concurrent finasteride Radiotherapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to \> 25% of skeleton * No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium-containing compounds (e.g., Metastron® or Quadramet®) Surgery * Not specified Other * More than 4 weeks since prior PC-SPES * More than 4 weeks since prior investigational therapy (medications or devices) * At least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity * At least 1 week since prior antiplatelet medication, including the following: * Abciximab * Cilostazol * Clopidogrel * Dipyridamole * Ticlopidine * No concurrent anticoagulant medications (for platelet count \< 50,000/mm\^3), including the following: * Dalteparin * Danaparoid * Enoxaparin * Heparin * Warfarin * No other concurrent investigational therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location
Suspended
New York Weill Cornell Cancer Center at Cornell UniversityNew York, United States
Suspended
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, United States

Completed3 Study Centers
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