A multicenter trial of interleukin-2 and low-dose cyclophosphamide in highly chemotherapy-resistant malignancies.

Abstract

The anti-tumor activity of high-dose recombinant interleukin-2 (IL-2) has been demonstrated in several recent preclinical and clinical studies. In an attempt to study possible synergistic effects with low-dose cyclophosphamide (CYC), a phase II clinical trial was initiated in 32 patients, 18 with malignant melanoma (MM) and 14 with renal cell carcinoma (RCC). The recombinant IL-2 (Cetus Corp., Emeryville, Ca, U.S.A.) was given once daily at 3 x 10(6) U/m2, as a 30-min infusion for 14 days in cycle I and for five days twice in cycles II and III, respectively; if tolerated, the dose was escalated to a maximum of 6 x 10(6) U/m2/day; the cycles, separated by 1-week treatment-free intervals, were each preceded by a single i.v. bolus of CYC at 350 mg/m2. The most prominent side-effects encountered in this trial consisted of a capillary leak syndrome, myalgia and fever requiring dose reduction in half of the patients during the first cycle. Given the limit of tolerable toxicities in a standard care unit, the regimen employed achieved minor anti-tumor activity. No objective responses were achieved in patients with RCC and a 15% remission rate (PR + MR) was seen in melanoma patients.

• Authors: A Lindemann, K Hoeffken, R E Schmidt, V Diehl, O Kloke, H Gamm, J Hayungs, W Oster, M Boehm, C R Franks
• Journal: Cancer treatment reviews (Cancer Treat Rev) Vol. 16 Suppl A Pg. 53-7 (Jun 1989) ISSN: 0305-7372 [Print] Netherlands
• PMID: 2670215 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Biomarkers, Tumor
• Interleukin-2
• Cyclophosphamide

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Biomarkers, Tumor (analysis)
• Carcinoma, Renal Cell (blood, drug therapy, secondary)
• Cyclophosphamide (administration & dosage)
• Drug Administration Schedule
• Drug Resistance
• Eosinophils
• Humans
• Interleukin-2 (administration & dosage, adverse effects)
• Kidney Neoplasms (blood, drug therapy)
• Leukocyte Count
• Lymphocytes
• Melanoma (drug therapy, physiopathology, secondary)
• Middle Aged
• Monitoring, Physiologic
• Multicenter Studies as Topic
• Remission Induction