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 I Treatment Closed 18 and over MSKCC-93029 NCI-B92-0002, B92-0002

Objectives

I.  Determine whether deoxyspergualin (DSG) administration results in 
diminution or ablation of the anti-murine antibody response following 
intravenous 131I-labeled monoclonal antibody CC-49 (131I-CC49) in patients 
with incurable colorectal malignancy, with antibody response determined by the 
following:  changes in HAMA titer; changes in the pharmacokinetics of 
subsequent 131I-CC49 infusions; relative uptake of radioactivity by tumor(s) 
and normal tissue after first and repeat infusions of 131I-CC49 as determined 
by serial whole-body and SPECT gamma camera imaging; and whole-body 
radioactivity biodistribution as estimated by serial gamma camera imaging and 
conjugate view methods.

II.  Determine the toxicity of DSG and multiple radiolabeled antibody 
administration in patients with advanced colorectal cancer.

III.  Determine the therapeutic efficacy of repeated infusions of 131I-CC49 
with DSG.

Entry Criteria

Disease Characteristics:

Histologically confirmed colorectal adenocarcinoma that is
considered inoperable and patient meets at least 1 of the
following requirements:
  Failed systemic chemotherapy
  Failed intra-arterial chemotherapy for hepatic metastases
  Refused conventional chemotherapy

TAG-72 antigen expression detected by immunoperoxidase staining
required
  At least 50% of tumor cells react with CC-49, with
  significant reactivity of surrounding mucin (if any)

Measurable or evaluable disease required

No active CNS metastases

Prior/Concurrent Therapy:

Recovery from toxicity of prior therapy required

Biologic therapy:
  No prior murine monoclonal antibody therapy
  No more than 1 prior course of immunotherapy

Chemotherapy:
  See Disease Characteristics

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior abdominal, pelvic, or intraperitoneal radiotherapy
  No concurrent radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 6 months

Hematopoietic:
  WBC greater than 3,500
  Platelets greater than 100,000

Hepatic:
  Bilirubin no greater than 2.0 mg/dl

Renal:
  Creatinine no greater than 2.0 mg/dl OR
  Creatinine clearance at least 40 ml/min

Cardiovascular:
  No NYHA class III/IV status

Other:
  No HAMA positivity
  No serious infection requiring antibiotics
  No illness requiring steroids
  No other significant medical disease that would preclude
     protocol therapy
  No pregnant or nursing women (negative pregnancy test
     required of fertile women)

Expected Enrollment

Six patients will be accrued over approximately 4 months.

Outline

Nonrandomized study.

Radiolabeled Immunoconjugate Therapy with Immunomodulation.  131I-Labeled 
Murine Monoclonal Antibody CC-49 (NSC-620537), 131I-CC49; with 
Deoxyspergualin, DSG, NSC-356894.

Divgi CR, Scott AM, Gulec S, et al.: Pilot radioimmunotherapy trial with 131I-labeled murine monoclonal antibody CC49 and deoxyspergualin in metastatic colon carcinoma. Clin Cancer Res 1 (12): 1503-10, 1995.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Chaitanya Divgi, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-2000; 800-525-2225