RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating
patients who have advanced cancer.
OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin
receptor antibodies with one antibody administered by itself for 1 hour before the second
antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies
E2.3 and A27.15.
OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15
IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody
E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects,
treatment continues once every 4 weeks in patients achieving minimal, partial, or complete
remission. Treatment ceases in patients experiencing stable or progressive disease. In the
absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6
patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the
same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose
level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are
followed for 3 weeks.
PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.
DISEASE CHARACTERISTICS: Refractory or recurrent advanced malignancy following known
standard effective therapy or advanced malignancy for which no standard effective therapy
exists Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At
least 2 months Hematopoietic: Absolute neutrophil count at least 1800/mm3 Hematocrit at
least 30 mg/dL Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5
times normal unless due to disease, then less than 3.5 times normal Transaminases less
than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to liver
metastases) Renal: Creatinine no greater than 2.5 times normal Cardiovascular: No severe
cardiac abnormalities Must have adequate venous access No history of sustained ventricular
arrhythmia or unexplained syncope Pulmonary: No severe pulmonary abnormalities Other: Not
pregnant or nursing Effective contraception required of fertile female patients No serious
concurrent medical or psychiatric illness Adequate nutrition No human antimouse antibodies
PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy and recovered If
there was disease progression during therapy, at least 2 weeks since prior anticancer
therapy and recovered Biologic therapy: Not specified Chemotherapy: No concurrent
chemotherapy Endocrine therapy: Concurrent topical steroids used in the chronic management
of cutaneous T cell lymphoma allowed No other concurrent hormone therapy Radiotherapy: No
concurrent palliative radiotherapy Surgery: Not specified