Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00024232
• Other study ID #: MSKCC-01030
• Secondary ID: CDR0000068903NCI
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: June 17, 2013
• Start date: June 2001
• Est. completion date: February 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• monoclonal antibody huJ591

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,