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-2112 NCI-T91-0218C, T91-0218

Objectives

I.  Determine the objective response rate to 131I-labeled  monoclonal antibody 
CC-49 (MOAB 131I-CC49) in patients with metastatic prostate cancer that has 
failed first-line hormonal therapy.

II.  Determine the toxicity of MOAB 131I-CC49 administered at 75 mCi/sqm 
intravenously in this patient population.

III.  Determine the frequency and magnitude of human immune response following 
administration of MOAB 131I-CC49.

IV.  Determine the ability of MOAB 131I-CC49 to localize to metastatic tumor 
sites.

V.  Estimate the dosimetry to whole body, specific organs, and tumor sites.

Entry Criteria

Disease Characteristics:

Histologically confirmed, metastatic prostate carcinoma that
has failed hormonal therapy

  Biopsy confirmation of metastatic disease required if PSA
and
  acid phosphatase are normal

TAG-72 antigen-positive tissue sample (immunoperoxidase
method)
required

Evaluable disease required

Prior/Concurrent Therapy:

Biologic therapy:
  Prior immunotherapy allowed
  Recovery from toxicity of prior immunotherapy required
  No concurrent immunotherapy 
  Prior therapy with murine monoclonal antibody allowed
     provided serum human anti-mouse antibody assay to CC-49
is
     negative

Chemotherapy:
  No prior cytotoxic chemotherapy
  No concurrent chemotherapy

Endocrine therapy:
  Previously instituted hormonal therapy allowed on study
  provided no new hormonal manipulations are initiated

Radiotherapy:
  No prior radiotherapy to spine or pelvis
  Recovery from toxicity of prior radiotherapy required
  No concurrent radiotherapy    

Surgery:
  Not specified

Patient Characteristics:

Age:
  At least 18

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

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

Hepatic:
  Bilirubin less than 1.5 mg/dl
  SGOT/SGPT no more than 4 x normal

Renal:
  Creatinine clearance at least 50 ml/min

Other:
  No history of iodine allergy
  No other malignancy except basal cell carcinoma
  HIV negative (by Western blot if ELISA positive)
  HBsA negative

Expected Enrollment

If at least 1 response is seen in the first 15 patients treated, a total of 30 
patients will be accrued.  Initial accrual of 15 patients should be completed 
within 12 months.

Outline

Nonrandomized study.

Radioimmunotherapy.  131I-Labeled Monoclonal Antibody CC-49, MOAB 131I-CC49, 
NSC-620537.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Albert LoBuglio, MD, Protocol chair(Contact information may not be current)		Ph: 205-975-7162