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Annals of Oncology 11:1387-1389, 2000
© 2000 European Society for Medical Oncology

research-article

A phase I-II study of 9-cis retinoic acid and interferon-{alpha}2b in patients with advanced renal-cell carcinoma: An NCIC Clinical Trials Group study

W. H. Miller, Jr1,, L. M. Reyno2, G. R. Loewen3, S. Huan4, E. Winquist5, M. Moore6, A. Cato, III3, D. Jaunakais3, J. A. Truglia3, S. Matthews7, J. Dancey7 and E. Eisenhauer7

1Department of Oncology, McGill University Montreal, PQ
2Hamilton Regional Cancer Centre Hamilton, Ontario, Canada
3Ligand Pharmaceuticals Inc. San Diego, California, USA
4Ottawa Regional Cancer Centre Ottawa
5London Regional Cancer Centre Landon
6Princess Margaret Hospital Toronto
7NCIC Clinical Trials Group, Queen's University Kingston, Ontario, Canada

Correspondence to: Dr W. H. Miller, Jr Lady Davis Institute Jewish General Hospital and McGill Centre for Translational Research in Cancer, 3755 Chemin de la Cote-Ste-Catherine Montreal, Quebec H3T 1E2 Canada E-mail: wmiller{at}ldi.jgh.mcgill.ca

Although advanced renal-cell carcinoma (RCC) responds poorly to standard therapies, phase I–II trials have shown activity for combinations of interferon-{alpha}2b (IFN) with a retinoid. Alitretinoin (9-cis RA) is an endogenous retinoid with high binding affinity for both RAR and RXR receptor families. This phase I–II study enrolled 38 patients with RCC in a dose-escalation study of tolerability, pharmacokinetics (PK), and efficacy of twice daily oral 9-cis RA with subcutaneous IFN. In contrast to studies with similar doses of daily 9-cis RA, PK studies found a consistent reduction in 9-cis RA concentrations of about 50% after multiple b.i.d. doses of 30 or 50 mg/m2, independent of cotreatment with IFN. In the phase I portion, toxicities included systemic symptoms typical of IFN and biochemical abnormalities previously associated with retinoids. Two patients experienced dose-limiting toxicity at 50 mg/m2 b.i.d. of 9-cis RA, thus the recommended phase II dose was 30 mg/m2 b.i.d. One of twenty-six evaluable patients achieved a durable objective partial remission, and repeated dosing with this regimen was poorly tolerated. This combination of retinoid and interferon is not recommended for further study in RCC.

interferon-{alpha}, pharmacokinetics, renal carcinoma, retinoids


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