Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UAC-2131 NCI-T92-0169C, T92-0169

Objectives

I.  Determine the objective response rate to 131I-labeled anti-TAG-72 
monoclonal antibody (131I-MOAB CC-49) with adjunctive interferon alpha (IFN-A).

II.  Determine the toxicity of 76 mCi/sqm of 131I-MOAB CC-49 with 8 daily 
doses of 3 MU IFN-A.

III.  Determine the frequency and magnitude of the human immune response to 
murine MOAB CC-49 in patients receiving cyclosporine.

IV.  Evaluate the ability of IFN-A to enhance the frequency of 131I-MOAB CC-49 
localization to different metastatic sites as determined by imaging studies.

V.  Determine the increase in radiation dose to different organs and tumor 
sites attributed to adjunctive IFN-A following administration of 131I-MOAB 
CC-49 with and without IFN-A.

Entry Criteria

Disease Characteristics:

Histologically confirmed metastatic prostate carcinoma that has
failed hormonal therapy
  Metastasis with normal PSA and acid phosphatase must have
  prostatic origin confirmed histologically

Tumor must be TAG-72 positive on immunoperoxidase staining of
original tissue blocks

Measurable disease required

Prior/Concurrent Therapy:

Recovery from all previous therapy required

Biologic therapy:
  No limit to prior immunotherapy
  No concurrent immunotherapy

Chemotherapy:
  No prior chemotherapy
  No concurrent chemotherapy

Endocrine therapy:
  No concurrent new hormonal therapy
     Previously instituted hormonal therapy allowed if
     unchanged

Radiotherapy:
  No prior radiotherapy to 20% or more of active bone marrow
  No concurrent radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60-100% (ECOG 0-2)

Hematopoietic:
  WBC at least 4,000
  Platelets at least 125,000
  Hb greater than 10 g/dl
  No nucleated RBC or significant tear-drop RBC morphology

Hepatic:
  No history of severe liver disease
  Bilirubin less than 1.5 mg/dl
  SGOT/SGPT no more than 4 x normal

Renal:
  No history of severe renal disease
  Creatinine clearance (estimated) at least 50 ml/min

Cardiovascular:
  No history of severe cardiac disease
  No history of or high risk for thromboembolic phenomena

Neurologic:
  No history of or high risk for seizure disorder
  No history of or high risk for compromised CNS function

Other:
  No history of allergy to:
     Iodine
     Cyclosporine
     Penicillin
     Mouse Ig
     Interferon
  Negative HAMA to MOAB CC-49 required if previously exposed to
     monoclonal antibodies
  Negative HIV antibody by ELISA or negative Western blot if
     ELISA positive
  Negative HBsAg
  No history of invasive second malignancy except basal cell
     carcinoma of the skin

Expected Enrollment

A maximum of 37 patients will be entered at a rate of 14 patients per year.  
If 3 or fewer of the first 17 respond, the study will be closed.

Outline

Nonrandomized study.

Radioimmunotherapy with Nonspecific Immune-Modulator Therapy.  131I-Labeled 
Anti-TAG-72 Monoclonal Antibody, 131I-MOAB CC-49, NSC-620537; with Interferon 
alpha (Schering), IFN-A, NSC-377523; Cyclosporine, CYSP, NSC-290193.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Ruby Meredith, MD, PhD, Protocol chair		Ph: 205-934-2763