Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

NCT ID: NCT00024232

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2004-02-29

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

monoclonal antibody huJ591

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Michael Morris, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000068903

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G01-2013

Identifier Type: -

Identifier Source: secondary_id

MSKCC-01030

Identifier Type: -

Identifier Source: org_study_id