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Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lutetium Lu 177 monoclonal antibody J591
Sponsored by
Memorial Sloan Kettering Cancer Center
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, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

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

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
July 9, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081172
Brief Title
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
Official Title
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

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, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
lutetium Lu 177 monoclonal antibody J591
Primary Outcome Measure Information:
Title
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Morris, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

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