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

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed over 18 NCI JMC-9309057 NCI-H96-0001

Objectives

I.  Evaluate the immunogenicity and toxicity of different doses of the rat 
monoclonal anti-idiotypic antibody BR3E4 (Ab2) with alum as adjuvant in 
patients with surgically incurable colorectal cancer.

II.  Assess the response to Ab2 in these patients.

Entry Criteria

Disease Characteristics:

Histologically documented colorectal cancer that is surgically incurable

Expression of 17-1A antigen determined in paraffin tumor sections

Prior/Concurrent Therapy:

Biologic therapy:
  No prior rat antibody

Chemotherapy:
  At least 3 weeks since chemotherapy (6 weeks since nitrosoureas or
  mitomycin)

Endocrine therapy:
  No current or imminent steroid therapy

Radiotherapy:
  At least 8 weeks since radiotherapy

Surgery:
  At least 4 weeks since surgery

Patient Characteristics:

Age:
  Over 18

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 6 months

Hematopoietic:
  WBC at least 3,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dL

Renal:
  Creatinine no greater than 1.5 mg/dL

Cardiovascular:
  No EKG evidence of active cardiac disease

Pulmonary:
  No history of active pulmonary disease

Immunologic:
  No history of hypersensitivity to rat protein
  No history of autoimmune disease or other major immune function abnormality
  At least 1 positive DTH response to recall antigens or dinitrofluorobenzene
     after sensitization

Other:
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

24 patients will be entered.

Outline

Biological Response Modifier Therapy.  Rat monoclonal anti-idiotypic CO 17-1A 
antibody, Ab2 BR3E4; with Alum.

Trial Contact Information

Trial Lead Organizations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Edith Mitchell, MD, FACP, Protocol chair		Ph: 215-955-8874; 800-533-3669 Email: Edith.Mitchel@jefferson.edu