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Phase I Trial of Monoclonal Antibody muJ591 in Patients With Hormone-Independent Prostate Cancer

Phase 1
21 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase I Trial of Monoclonal Antibody muJ591 in Patients With Hormone-Independent Prostate Cancer

OBJECTIVES: I. Define the toxicity and maximum tolerated dose of monoclonal antibody muJ591
in patients with hormone independent prostate cancer. II. Define the pharmacokinetics and
biodistribution of monoclonal antibody muJ591 in these patients. III. Define the human
antimouse antibody response to this therapy. IV. Define the preliminary efficacy of this
therapy in these patients.

OUTLINE: This is a dose escalation study. Patients receive a single dose of intravenous
iodine I 131-labeled monoclonal antibody muJ591 on day 0, combined with an unlabeled (cold)
dose of monoclonal antibody muJ591. Anterior and posterior imaging is obtained 1 hour after
labeled muJ591 administration and on days 0, 2, 4, and 6. Subsequent cohorts of 3-6 patients
receive fixed iodine-labeled doses with escalating cold doses of monoclonal antibody muJ591
until the maximum tolerated dose is reached. Patients are followed for a minimum of 8 weeks
after muJ591 therapy or until disease progression. Patients with stable or responding
disease who are human anti-mouse antibody negative may receive subsequent treatments at the
discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate,
defined by: Abnormal CT, MRI, or bone scan and/or Rising prostate specific antigen (PSA)
levels (on 3 consecutive occasions over at least 6 weeks) despite hormonal therapy PSA at
least 2.0 at study entry No active CNS metastases

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count
greater than 100,000/mm3 No serious hematologic disease Hepatic: SGOT less than 2.0 times
upper limit of normal Bilirubin less than 1.5 mg/dL No serious hepatic disease Renal:
Creatinine less than 2.0 mg/dL Calcium less than 13.5 mg/dL No serious renal disease
Cardiovascular: No active angina No New York Heart Association class III-IV No other
serious cardiac disease Pulmonary: No serious respiratory disease Other: No active
uncontrolled infection Evidence of pre-existing antimouse antibody at the time of

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior cytotoxic chemotherapy Endocrine therapy: At least 6 weeks since prior adrenal
hormone inhibitors or corticosteroid therapy Antiandrogen therapy must be discontinued
prior to measuring PSA values Luteinizing hormone-releasing hormone analog must be
maintained during study OR must be discontinued at least 10 weeks prior to study entry
(for 28 day depot preparation) or 24 weeks prior to study entry (for 3 month depot
preparation) Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Neil H. Bander, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



New York Presbyterian Hospital - Cornell Campus New York, New York  10021