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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody huJ591
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 stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Disease progression after prior castration At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI Testosterone no greater than 50 ng/mL Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy Progression of disease after discontinuation of prior anti-androgen therapy No requirement for palliative therapy within the past 12 weeks No active CNS or epidural primary tumor OR active CNS or epidural metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Gamma-glutamyl-transferase less than upper limit of normal (ULN) AST less than ULN PT less than 14 seconds No prior autoimmune hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically significant cardiac disease (New York Heart Association class III or IV) Pulmonary: No severe debilitating pulmonary disease Other: Fertile patients must use effective contraception No active uncontrolled infection or infection requiring IV antibiotics No prior autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine protein for diagnostic or therapeutic purposes No other concurrent anticancer immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent anticancer chemotherapy Endocrine therapy: See Disease Characteristics No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion Surgery: See Disease Characteristics No concurrent surgery Other: Recovered from all prior therapy At least 4 weeks since prior therapeutic investigational anticancer drugs At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans No other concurrent therapeutic investigational anticancer agents No concurrent participation in other therapeutic clinical trial with an experimental drug

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024232
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Official Title
Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer. Determine the biodistribution and dosimetry of this antibody in these patients. Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients. Determine the HAHA response in patients treated with this regimen. Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients. OUTLINE: Patients are assigned to one of two treatment groups. Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1. Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I. Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for 4 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) 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
stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody huJ591

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Disease progression after prior castration At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI Testosterone no greater than 50 ng/mL Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy Progression of disease after discontinuation of prior anti-androgen therapy No requirement for palliative therapy within the past 12 weeks No active CNS or epidural primary tumor OR active CNS or epidural metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Gamma-glutamyl-transferase less than upper limit of normal (ULN) AST less than ULN PT less than 14 seconds No prior autoimmune hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically significant cardiac disease (New York Heart Association class III or IV) Pulmonary: No severe debilitating pulmonary disease Other: Fertile patients must use effective contraception No active uncontrolled infection or infection requiring IV antibiotics No prior autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine protein for diagnostic or therapeutic purposes No other concurrent anticancer immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent anticancer chemotherapy Endocrine therapy: See Disease Characteristics No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion Surgery: See Disease Characteristics No concurrent surgery Other: Recovered from all prior therapy At least 4 weeks since prior therapeutic investigational anticancer drugs At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans No other concurrent therapeutic investigational anticancer agents No concurrent participation in other therapeutic clinical trial with an experimental drug
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

12. IPD Sharing Statement

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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

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