Phase I trial of murine monoclonal antibody L6 in combination with subcutaneous interleukin-2 in patients with advanced carcinoma of the breast, colorectum, and lung.

PURPOSE: A phase I trial was undertaken to determine the toxicity and biologic effects of a combination of murine monoclonal antibody L6 (MoAb L6) plus subcutaneous (SC) interleukin-2 (IL-2). PATIENTS AND METHODS: Fifteen patients with refractory adenocarcinoma (five breast, five lung, five colorectal), received L6 at 200 mg/m2 intravenously (IV) daily on days 1 to 7, followed by a 1-week rest period. IL-2 was given at either 2, 3, or 4.5 x 10(6) U/m2 daily doses times 4 days for a total duration of 3 weeks. RESULTS: Side effects of L6 consisted of mild fever and chills along with a rash and serum sickness in one patient. One patient developed dyspnea and urticaria, that resolved with antihistamines. Maximum-tolerated dose (MTD) of SC IL-2 was 3 x 10(6) U/m2, with dose-limiting toxicities that consisted of grade 4 fatigue and dyspnea. Significant decreases in complement levels along with increases in absolute lymphocyte count and eosinophil count were observed. Mean antibody-dependent cellular cytotoxicity from mononuclear cells taken from patients who received IL-2 was elevated significantly compared with baseline in all patients independent of IL-2 dose (P less than .05). Serum IL-2 levels were elevated in 13 of 14 patients (range, 0.9 to 100 U/mL). Human antimouse antibody (HAMA) titers were elevated in nine of 14 (64%) patients who were tested between 3 and 8 weeks after L6 infusion. One patient with breast cancer had a transient mixed response, and one patient with colorectal cancer had a partial response. CONCLUSIONS: L6 and SC IL-2 were well tolerated in the majority of patients when given in the outpatient setting. In view of the clinical efficacy of this combination, more phase II trials are warranted.

[Resuscitation during renal transplantation in children]. / Réanimation en transplantation rénale chez l'enfant.

Over a 4 yr-period, 60 children (aged 10 months to 17 yr) received 66 kidney transplants with the same surgical intensive care program, the fist 48 hr-period of which has been analysed in this study. Thirty percent of recipients were transplanted without previous dialysis and in 8%, body weight was below 10 kg at the time of surgery. The duration of anesthesia was 4.4 +/- 1.0 h and 32% received locoregional anesthesia. The mean duration for cold ischemia was 14.7 +/- 11.7 h and 26 +/- 7 min for warm ischemia; diuresis began during the operation in 79% of the patients. Routine vascular filling consisted of standard isotonic solute (11 +/- 4 ml/kg/h) associated with mannitol infusion; 59% of recipients required 20% human serum albumin and 42% blood transfusion. Post-operative diuresis was 7.4 +/- 6.0 ml/kg/h during the first 24 h, and sometimes resulted in hypovolemic episodes; 9% of the patients had primary non-functioning kidneys (4 transient acute tubular necrosis; 2 vascular thrombosis) and 4% required dialysis; the 1-yr survival rate was 82% for the grafts and 98% of the patients.

Supraventricular tachycardia in infants: use of the "diving reflex".

The effectiveness of the "diving reflex" in treating paroxysmal supraventricular tachycardia (PSVT) in 10 infants aged under 6 months is demonstrated. No rhythm disturbances were encountered during the maneuver, even in patients receiving digitalis. The recommended water temperature is 5 degrees C and the total time of facial immersion, between 6 and 7 seconds. The diving reflex might be considered the first therapeutic approach in infants under 6 months old with PSVT.