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A Phase I Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma

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Division of Hematology/Oncology, Northwestern University, 676 N. St Clair, Suite 850, Chicago, IL 60611, USA
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Department of Medicine, Northwestern University, 251 E. Huron, Galter Suite 3-150, Chicago, IL 60611, USA
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Division of Biostatistics, Department of Preventative Health, Feinberg School of Medicine, Northwestern University, 680 N. Lakeshore Drive, Suite 1400, Chicago, IL 60611, USA
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Author to whom correspondence should be addressed.
J. Pers. Med. 2014, 4(4), 448-458; https://doi.org/10.3390/jpm4040448
Received: 19 August 2014 / Revised: 18 September 2014 / Accepted: 23 September 2014 / Published: 17 October 2014
Background: Temozolomide is efficacious as an oral alternative for patients with metastatic melanoma (MM). Calcitriol has anti-proliferative properties and vitamin D receptor (VDR) polymorphisms are associated with alterations in melanoma susceptibility and progression. Methods: Tem 150 mg/m2 was administered on days 2–8 and 16–22 every 28 days. Calcitriol was given on days 1 and 15 every 28 days. VDR gene analysis was completed using PCR-RFLP based assays. Tolerability was the primary objective with secondary objectives of time to progression (TTP) and overall survival (OS). Results: Twenty pts with MM were registered. Cytopenias and thrombosis were the most common grade 3 or 4 toxicities. Median TTP was 1.8 mo. Pts with high-risk VDR genotype tt+/−ff (n = 6) had an OS of 3.8 mo from time of enrollment, compared to 7.4 mo for those with non-tt/ff genotypes (n = 11), although not statistically significant (HR = 1.20, 95% CI 0.41–3.53, p = 0.74). Conclusions: The extended dosing of Tem with calcitriol is a well-tolerated regimen. The trend toward improved OS in non-tt/ff VDR genotypes is consistent with prior studies associating the tt/ff genotype with biologic aggressiveness. View Full-Text
Keywords: metastatic melanoma; vitamin D receptor polymorphisms; temozolomide; calcitriol; Taq1; Fok1 metastatic melanoma; vitamin D receptor polymorphisms; temozolomide; calcitriol; Taq1; Fok1
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Pettijohn, E.; Martone, B.; Rademaker, A.; Kuzel, T. A Phase I Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma. J. Pers. Med. 2014, 4, 448-458.

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