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J. Pers. Med. 2014, 4(4), 448-458; doi:10.3390/jpm4040448

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

1
Division of Hematology/Oncology, Northwestern University, 676 N. St Clair, Suite 850, Chicago, IL 60611, USA
2
Department of Medicine, Northwestern University, 251 E. Huron, Galter Suite 3-150, Chicago, IL 60611, USA
3
Division of Biostatistics, Department of Preventative Health, Feinberg School of Medicine, Northwestern University, 680 N. Lakeshore Drive, Suite 1400, Chicago, IL 60611, USA
*
Author to whom correspondence should be addressed.
Received: 19 August 2014 / Revised: 18 September 2014 / Accepted: 23 September 2014 / Published: 17 October 2014
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Abstract

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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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

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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J. Pers. Med. EISSN 2075-4426 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
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