A phase-II study of low-dose cyclophosphamide and recombinant human interleukin-2 in metastatic renal cell carcinoma and malignant melanoma Journal Article
| Authors: | Lindemann, A.; Höffken, K.; Schmidt, R. E.; Diehl, V.; Kloke, O.; Gamm, H.; Hayungs, J.; Oster, W.; Böhm, M.; Kolitz, J. E.; Franks, C. R.; Herrmann, F.; Mertelsmann, R. H. |
| Article Title: | A phase-II study of low-dose cyclophosphamide and recombinant human interleukin-2 in metastatic renal cell carcinoma and malignant melanoma |
| Abstract: | Recent preclinical and clinical studies that have demonstrated antitumor activity of high-dose recombinant interleukin-2 (rIL-2), and animal models that demonstrated a synergistic effect of low-dose cyclophosphamide, led us to study rIL-2 (Cetus Corp., Emeryville, Calif) in a phase II clinical trial in combination with low-dose cyclophosphamide in 32 patients, 18 with malignant melanoma and 14 with renal cell carcinoma. rIL-2 was given once daily at 3×106 U/m2, as a 30-min infusion for 14 days in cycle I and for 2×5 days in cycles II and III respectively; if tolerated, the dose was increased to a maximum of 6×106 U m-2 day-1; the cycles, separated by 1 week treatment-free intervals, were preceded each by a single i.v. bolus of cyclophosphamide at 350 mg/m2. The most prominent side-effects encountered in this trial consisted of a capillary leak syndrome, myalgia and fever that required dose reduction during the first cycle in one-half of the patients. Given the limit of tolerable toxicities in a standard care unit, the regimen employed achieved minor antitumor activity. No remission was achieved in patients with renal cell carcinoma, and 15% of melanoma patients showed objective responses (partial response + minor response). © 1989 Springer-Verlag. |
| Keywords: | adult; clinical article; aged; phenotype; melanoma; phase 2 clinical trial; antineoplastic combined chemotherapy protocols; myalgia; drug administration schedule; cyclophosphamide; kidney carcinoma; kidney neoplasms; age; fever; recombinant proteins; carcinoma; neoplasm metastasis; blood vessel injury; remission induction; blood cell count; intravenous drug administration; interleukin-2; recombinant interleukin 2; middle age; receptors, interleukin-2; drug evaluation; human; male; female; support, non-u.s. gov't |
| Journal Title: | Cancer Immunology, Immunotherapy |
| Volume: | 28 |
| Issue: | 4 |
| ISSN: | 0340-7004 |
| Publisher: | Springer |
| Date Published: | 1989-04-01 |
| Start Page: | 275 |
| End Page: | 281 |
| Language: | English |
| DOI: | 10.1007/bf00205237 |
| PUBMED: | 2784715 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 14 April 2020 -- Source: Scopus |
