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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI UAC-2110 NCI-T91-0203C, T91-0203

Objectives

I.  Determine the objective response rate produced by 131I-labeled monoclonal 
antibody CC49 (MOAB 131I-CC49) in patients with colorectal cancer.

II.  Assess the potential of interleukin-1-beta (IL-1B) for preventing the 
myelosuppression produced by radioimmunotherapy.

III.  Determine the toxicity of IL-1B plus MOAB 131I-CC49 in patients with 
colorectal cancer.

IV.  Determine the effects of IL-1B on the pharmacokinetics and human immune 
response to MOAB CC49.

Entry Criteria

Disease Characteristics:

Histologically confirmed, unresectable colorectal carcinoma

Bidimensionally measurable disease (by physical exam or
conventional imaging procedures) outside any previous
radiotherapy ports required

No active CNS tumor involvement

TAG-72 antigen content assessment by immunoperoxidase methods
on fresh tissue or tissue blocks required

Prior/Concurrent Therapy:

Biologic therapy:
  No limits on prior immunotherapy
  Negative HAMA to CC49 required in patients previously
     exposed to monoclonal antibodies
  At least 4 weeks since prior immunotherapy
  Recovery from toxicity of prior immunotherapy required

Chemotherapy:
  One prior chemotherapy regimen allowed
  No prior mitomycin or nitrosoureas
  At least 4 weeks since prior chemotherapy
  Recovery from toxicity of prior chemotherapy required
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior abdominal, pelvic, or intraperitoneal radiotherapy
  At least 4 weeks since prior radiotherapy
  Recovery from toxicity of prior radiotherapy required
  No concurrent radiotherapy

Surgery:
  At least 14 days since any prior surgery
  Recovery from surgery required

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

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

Renal:
  Creatinine clearance at least 50 ml/min

Cardiovascular:
  No cardiovascular disease requiring therapy or restricting
  activity that would limit tolerance to study agents

Other:
  No history of iodine allergy
  No active infection requiring antibiotic therapy
  HIV and HBsAg seronegative
  No diabetes mellitus or other medical condition requiring
     therapy or restricting activity that would limit
     tolerance to study agents
  No pregnant or nursing women
  Effective contraception required of fertile patients (or
     their partners)

Expected Enrollment

14 patients will be accrued over 1 year.  28 patients entered on studies of 
MOAB 131I-labeled CC49 alone at M.D. Anderson and Memorial Sloan Kettering 
will serve as control patients.

Outline

Nonrandomized study.

Radioimmunoconjugate Therapy with Hematologic Toxicity Attenuation.  
131I-Labeled Murine Monoclonal Antibody CC49, MOAB 131I-CC49, NSC-620537; with 
Interleukin-1-beta (Syntex), IL-1B, NSC-647860.

Wheeler RH, Meredith RF, Saleh MN, et al.: A phase II trial of IL-1 + radioimmunotherapy (RIT) in patients (PTS) with metastatic colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-959, 295, 1994.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Richard Wheeler, MD, Protocol chair(Contact information may not be current)		Ph: 801-585-0303; 877-585-0303