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Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer

NCT ID: NCT00195039

Last Updated: 2017-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.

Detailed Description

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To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer.

Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.

Group Type EXPERIMENTAL

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)

Intervention Type DRUG

Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.

Interventions

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177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)

Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic diagnosis of prostate adenocarcinoma.
* Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
* Progressed following discontinuation of anti-androgen therapy, if received.
* Serum testosterone \< 50 ng/ml

Exclusion Criteria

* Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
* Use of PC-SPES within 4 weeks of treatment.
* Use of red blood cell or platelet transfusions within 4 weeks of treatment.
* Use of hematopoietic growth factors within 4 weeks of treatment.
* Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
* Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
* Prior radiation therapy encompassing \>25% of skeleton.
* Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
* Active angina pectoris or NY Heart Association Class III-IV.
* History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
* 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.
* Prior monoclonal antibody therapy with the exception of ProstaScint®
* Prior investigational therapy (medications or devices) within 6 weeks of treatment.
* Known history of HIV
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Tagawa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medcial College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

References

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S.T. Tagawa; M.I. Milowsky; M. J. Morris; S. Vallabhajosula; S. Goldsmith; D. Matulich; J. Kaplan; F. Berger; H. I. Scher; N. H. Bander; D. M. Nanus. Phase II trial of 177Lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 in patients with metastatic castrate-resistant prostate cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 5140)

Reference Type RESULT

Tagawa ST, Milowsky MI, Morris M, Vallabhajosula S, Christos P, Akhtar NH, Osborne J, Goldsmith SJ, Larson S, Taskar NP, Scher HI, Bander NH, Nanus DM. Phase II study of Lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2013 Sep 15;19(18):5182-91. doi: 10.1158/1078-0432.CCR-13-0231. Epub 2013 May 28.

Reference Type RESULT
PMID: 23714732 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33465252 (View on PubMed)

Other Identifiers

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0304006100

Identifier Type: -

Identifier Source: secondary_id

0304006100

Identifier Type: -

Identifier Source: org_study_id