Phase II trial of suramin in patients with advanced renal cell carcinoma: treatment results, pharmacokinetics, and tumor growth factor expression.

Twenty-six patients with advanced renal cell carcinoma were treated with suramin administered by continuous infusion, with dosing determined by a nomogram. One patient achieved a partial response and five patients achieved a minor response or had stable disease for > 3 months. Toxicities included an immune-mediated thrombocytopenia in one patient and Staphylococcus sepsis that was not associated with neutropenia in five patients. Pharmacokinetic parameters were determined by the ADAPT II MAP-Bayesian parameter estimation program. Patient data were fit using a two-compartment open model and first-order rate elimination. This showed a wide interpatient variation in time to target level (median, 13.8 days), volume of distribution (median, 15.2 liters/m2), and t1/2-beta (median, 20.6 days). The patients who achieved a partial response, minor response, or stable disease had a slower elimination rate of suramin, compared to patients with progressive disease. Tumor specimens were obtained prior to therapy and were analyzed for the production of five different growth factor-specific RNA transcripts. These included transforming growth factor alpha, acidic fibroblast growth factor, basic fibroblast growth factor, and platelet-derived growth factor types A and B. No difference in the pattern of growth factor expression was seen in tumors of responding and nonresponding patients. Suramin does not have significant antitumor activity in renal cell carcinoma. The wide variability in pharmacokinetics suggests that individual dosing should be used in future trials of suramin for treatment for other malignancies. Pertinent corollary studies of tumor biology and clinical pharmacology should be included whenever possible in clinical trials in patients with renal cell carcinoma.

A phase II trial of interleukin-2 and interferon alfa-2a in patients with advanced renal cell carcinoma.

PURPOSE: A phase II trial that used a regimen of interleukin-2 (IL-2) and interferon alfa-2a (IFN-alpha) was undertaken to evaluate the efficacy of this combination in the treatment of metastatic renal cell carcinoma. PATIENTS AND METHODS: Thirty-four assessable patients were treated with one to two induction cycles of IL-2 administered by continuous intravenous (IV) infusion at a dose of 3 x 10(6) U/m2/d [corrected] for 4 days per week plus IFN-alpha administered by subcutaneous injection at a dose of 5 x 10(6) U/m2/d [corrected] for 4 days per week for 3 consecutive weeks. A maintenance regimen of IL-2 2 x 10(6) U/m2/d [corrected] given by continuous IV infusion for 5 days per week plus IFN-alpha subcutaneously at a dose of 6 x 10(6) U/m2/d [corrected] that was given 3 days per week for 3 weeks was administered for one to five cycles. Twenty-eight patients (82%) completed one to two induction cycles, and 14 patients (41%) received maintenance doses. RESULTS: Major responses were achieved in four patients (12%), which included one complete response (CR) in a bone metastasis. Responses were observed in patients both with and without prior nephrectomy as well as in a primary tumor. Toxicity was moderately severe and included two treatment-related deaths. CONCLUSIONS: In view of the minimal antitumor activity and associated toxicity, the combination of IL-2 and IFN-alpha in this trial cannot be recommended. The investigation of new cytokines and the identification of biologic prognostic factors for a response to immunologic therapy are essential.

Successful removal of a curled central venous catheter using interventional radiologic techniques.

We describe an unusual complication encountered in a patient with a refractory, bulky lymphoma whose 'subclinical' superior vena caval obstruction caused the central venous catheter to curl upon placement. We believe the invasive radiologic techniques described in this report represent a viable alternative to the surgical resolution of such a problem.

Preaortic iliac venous confluence ("marsupial cava"): a rare anomaly of the inferior vena cava.

A patient was shown by computed tomography (CT) to have a rare developmental anomaly of the inferior vena cava (IVC), in which the iliac venous confluence is located anterior (rather than posterior) to the right common iliac artery. Recognition of the anomaly is important prior to surgical intervention in that area, as well as to prevent misinterpretation of the anomaly as representing adenopathy.

Complications of peripheral arteriography: a new system to identify patients at increased risk.

PURPOSE: The most quoted literature on arteriographic complications is based on self-reports collected during the mid 1970s. We sought to determine whether those results remain valid despite changes in arteriographic practice and whether patient subgroups at increased risk could be identified. METHODS: Five hundred forty-nine consecutive patients were examined after arteriography and twice over 72 hours. Patients were telephoned at least 2 weeks later to identify delayed complications. The sample was divided into two groups to allow independent validation of suspected prognostic factors. RESULTS: The rate of major complications was 2.9% (16/549), but varied from 0.7% to 9.1% among three strata of relative risk. Rates were highest in patients studied for suspected aortic dissection, mesenteric ischemia, gastrointestinal bleeding, or symptomatic carotid artery stenosis and lowest in patients with trauma or aneurysmal disease. Patients studied for claudication or limb-threatening ischemia had intermediate risk (2.0%). Within these strata, congestive heart failure and furosemide use were the only variables independently associated with a significantly increased complication rate. CONCLUSIONS: Previous reports have overestimated the risk of arteriography for trauma or aneurysm but substantially underestimate the risk for patients with other common conditions. Such stratified complication rates are essential to understand relative costs and benefits of arteriography and other vascular imaging modalities in specific clinical situations.

Sonographic guidance in diagnostic and therapeutic interventions in the pleural space.

One hundred eighty-seven diagnostic and therapeutic interventional procedures in the pleural space were performed by using sonographic guidance. These consisted of diagnostic aspiration (118), drainage of malignant and nonmalignant effusions (41), empyema drainage (17), pleural sclerotherapy with tetracycline or bleomycin (7), and pleural biopsy (4). Diagnostic aspiration was performed with 20-gauge needles, and therapeutic and empyema drainages were performed by trocar technique with either a 7-French Sacks catheter or a specially designed empyema drainage catheter. Pneumothoraces were seen in 3% of the patients, and most of these were treated by the radiologist with placement of a Heimlich valve. We conclude that the use of sonography allows rapid localization of pleural fluid collections and instant monitoring of drainage of noninfected fluid collections and empyemas.