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Phase I Evaluation of 131I-J591 Murine Monoclonal Antibody in Patients With Progressive Androgen-Independent Prostate Cancer

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase I Evaluation of 131I-J591 Murine Monoclonal Antibody in Patients With Progressive Androgen-Independent Prostate Cancer

OBJECTIVES: I. Determine the biodistribution and normal organ dosimetry of iodine I 131
monoclonal antibody muJ591 in patients with progressive androgen independent prostate
cancer. II. Determine the safety of this drug in these patients. III. Determine the
pharmacokinetics of this drug in these patients. IV. Determine the human antimouse antibody
response in these patients to this drug. V. Determine the antitumor effects of this drug in
these patients.

OUTLINE: This is a dose escalation study of iodine I 131 monoclonal antibody muJ591
(131I-J591). Patients receive unlabeled monoclonal antibody muJ591 IV over 1 hour followed
by 131I-J591 IV over 1 hour. Cohorts of 3-6 patients receive escalating doses of 131I-J591
(radioactivity is escalated, monoclonal antibody dose is fixed) until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients
experience dose limiting toxicity. Patients are followed at weeks 3, 4, 6, 8, 9, and 12, and
then every 6 months until month 21.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study over 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed androgen independent prostate cancer
that is progressing under castrate levels of testosterone Progression documented in one of
the following ways: A minimum of 3 rising PSA values from baseline obtained 1 week or more
apart or 2 measurements 2 weeks or more apart New osseous lesions on bone scan Greater
than 25% increase in bidimensionally measurable soft tissue disease, or the appearance of
new sites of disease Patients on an antiandrogen must have shown progression off of the
antiandrogen prior to study Testosterone no greater than 50 ng/mL No residual proctitis
following radiotherapy No active CNS or epidural primary tumor or metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm3 Hemoglobin greater
than 10 g/dL Platelet count greater than 150,000/mm3 Hepatic: Bilirubin less than 1.5
mg/dL GGT less than upper limit of normal (ULN) AST less than ULN PT less than 14 seconds
No autoimmune hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance
greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV
cardiac disease Pulmonary: No severe debilitating pulmonary disease Other: No active
uncontrolled infection or infection requiring IV antibiotic treatment No evidence of human
antimouse antibody No prior autoimmune disease No prior GI hemorrhage HIV negative Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 months since prior packed red blood
cell transfusion No prior murine or human antibody therapy No prior murine protein No
other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and
recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics
Concurrent gonadotropin releasing hormone analogs required for patients who have not
undergone surgical orchiectomy No other concurrent hormonal therapy Radiotherapy: See
Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior
diagnostic scintigram (e.g., ProstaScint, Myoscint, or Oncoscint) No prior radiotherapy to
more than the sternum alone OR No primary radiotherapy to the prostate and one other site
OR No prior radiotherapy to more than 25% of the skeleton No prior treatment with
strontium chloride Sr 89 or Samarium Sm 153 lexidronam pentasodium No concurrent
radiotherapy to localized sites (e.g.,bone) used as indicator lesions Surgery: No
concurrent surgery to sole site of measurable disease Other: At least 4 weeks since
investigational anticancer therapeutic drugs and recovered No concurrent aspirin,
nonsteroidal antiinflammitory agents, anticoagulants, or other drugs that may induce or
exacerbate a bleeding tendency

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard I. Scher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

March 2002

Related Keywords:

  • Prostate Cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021