Clinical trial NCT00195039: Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
Official title: A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Define the PSA Response Rate.
timeFrame: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
measure: Define the Measurable Disease Response Rate.
timeFrame: Disease will be assessed at baseline and day 85.
Secondary outcomes:
measure: Define the Duration of Biochemical PSA and/or Measurable Disease Response.
timeFrame: At baseline, and up to death
measure: Define the Toxicity of 177Lu-J591 Given as Single Dose.
timeFrame: From baseline until end of treatment phase (12 weeks)
measure: Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.
timeFrame: HAHA samples will be drawn at baseline and Day 85.
measure: Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).
timeFrame: Bone scan will be performed at baseline and Day 85.
measure: Assess the Survival Rate of Patients Following Treatment.
timeFrame: From baseline through study completion
measure: Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.
timeFrame: Scans will be performed between day 6 and 8.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medcial College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Scott Tagawa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)
citation: 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.
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.