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 Completed over 16 NCI MDA-DM-91009 NCI-T91-0073D, T91-0073

Objectives

I.  Determine the efficacy of deoxyspergualin (DSG) in reducing the human 
anti-mouse antibody response to the administration of the pancarcinoma murine 
monoclonal antibody L6 (MOAB L6) in patients with metastatic carcinomas of the 
breast, colon, and ovary and non-small cell carcinoma of the lung who have 
failed standard therapy.

II.  Assess the toxicity of DSG combined with MOAB L6 in these patients.

III.  Measure various immunologic parameters in peripheral blood, including 
murine antibody levels (in selected patients), serum complement levels, and 
lymphocyte markers.

IV.  Determine the plasma pharmacokinetics of DSG and MOAB L6.

V.  Observe and document the antitumor activity of DSG/MOAB L6 given in this 
manner in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven, primary metastatic carcinomas of the
following types:
  Non-small cell lung
  Breast
  Colon
  Ovary

Failed standard therapy

No CNS metastases

Evaluable disease required

Hormone receptor status (for breast cancer patients):
  Not specified

Prior/Concurrent Therapy:

Biologic therapy:
  No prior murine immunoglobulins for imaging or treatment
  At least 3 weeks since any prior immunotherapy

Chemotherapy:
  No prior deoxyspergualin
  At least 3 weeks since prior chemotherapy (6 weeks for
     mitomycin or nitrosoureas)

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 3 weeks since any prior radiotherapy

Surgery:
  Must be fully recovered from any prior surgery

Other:
  No requirement for ongoing therapy with corticosteroids,
  nonsteroidal anti-inflammatory agents, Antabuse, or
  monoamine oxidase inhibitors

Patient Characteristics:

Age:
  Over 16

Sex:
  Male and female

Menopausal status (for breast cancer patients):
  Not specified

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 3 months

Hematopoietic:
  WBC at least 4,000
  Granulocytes greater than 1,500
  Platelets at least 100,000
  Hb greater than 10.0 g/dl

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  PT less than 14 seconds
  PTT less than 35 seconds

Renal:
  Creatinine no greater than 2.0 mg/dl OR
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  NYHA class I
  Normal stress test required in the presence of suspected
     cardiac dysfunction (e.g., conduction defects on EKG)
  No angina
  No MI
  No arrhythmia

Other:
  No serious active infections or other intercurrent illness
  No known seizure disorder
  No HBsAg or HIV seropositivity
  No pregnant or lactating women
  Effective contraception required of fertile women

Expected Enrollment

14-24 evaluable patients will be studied.  It is anticipated that 3 patients 
per month will be entered, with 5-8 months required for completion of accrual; 
an estimated 9-15 months will be required for completion of the study.

Outline

Nonrandomized study.

Biological Response Modifier Therapy plus Single-agent Chemotherapy.  Murine 
Monoclonal Antibody L6, MOAB L6, NSC-620363; plus Deoxyspergualin, DSG, 
NSC-356894.

Dhingra K, Fritsche H, Murray J, et al.: Suppression of human antimouse antibody (HAMA) response by deoxyspergualin (DSG): a phase I study. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-945, 291, 1993.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Kapil Dhingra, MD, Protocol chair		Ph: 973-562-3493; 800-526-6367 Email: kapil.dhingra@roche.com