- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00081172
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSKCC-03144
- CDR0000360629 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on lutetium Lu 177 monoclonal antibody J591
-
OHSU Knight Cancer InstituteNovartis; Oregon Health and Science UniversityNot yet recruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Recurrent Breast Carcinoma | Metastatic Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnMetastatic Adrenal Gland Pheochromocytoma | Stage III Thyroid Gland Medullary Carcinoma AJCC v8 | Stage IV Thyroid Gland Medullary Carcinoma AJCC v8 | Locally Advanced Adrenal Gland Pheochromocytoma | Locally Advanced Paraganglioma | Metastatic Paraganglioma | Metastatic Parathyroid Gland Carcinoma and other conditionsUnited States
-
Bivision Pharmaceuticals, Inc.Recruiting
-
University Health Network, TorontoCancer Care Ontario; Ozmosis Research Inc.; Canadian Molecular Imaging Probe...Active, not recruitingNeuroendocrine TumorsCanada
-
Ralph NULL SalloumChildren's Hospital Medical Center, CincinnatiRecruitingHigh Grade Glioma | Medulloblastoma | Meningioma | Anaplastic Ependymoma | Recurrent Malignant Glioma | Recurrent Medulloblastoma | Refractory Malignant Glioma | Refractory Medulloblastoma | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Primary Central Nervous System Neoplasm | Refractory Primary... and other conditionsUnited States
-
Lawson Health Research InstituteActive, not recruiting
-
Marnix LamCompletedNeuroendocrine Tumors | Liver MetastasesNetherlands
-
Novartis PharmaceuticalsCompletedNeuroendocrine TumorUnited States
-
Jonsson Comprehensive Cancer CenterPOINT BiopharmaActive, not recruitingProstate Adenocarcinoma | Stage IVB Prostate Cancer AJCC v8 | Oligometastatic Prostate Carcinoma | Recurrent Prostate AdenocarcinomaUnited States
-
Weill Medical College of Cornell UniversityCompletedKidney Cancer | Breast Cancer | Head and Neck Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Non-small Cell Lung Cancer | GliomasUnited States