A Phase I Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma
Abstract
:1. Introduction
2. Experimental
2.1. Patient Eligibility/Selection
2.2. Study Design
2.3. Patient Evaluation
2.4. Vitamin D Receptor SNP Genotyping
2.5. Statistical Analysis
3. Results
3.1. Patient Characteristics
Characteristic | n = 20 |
---|---|
Median Age (range) | 58 (30–86) |
Race, n (%) | |
Caucasian | 20 (100) |
Gender, n (%) | |
Male | 15 (75) |
Female | 5 (25) |
Median time from initial diagnosis, years (range) | 2.4 (0.6–10) |
ECOG performance status, n (%) | |
0 | 9 (45) |
1 | 10 (50) |
2 | 1 (5) |
3.2. Drug Exposure
3.3. Safety/Toxicity
Toxicity | No. | % |
---|---|---|
Thrombocytopenia | 2 | 10 |
Vascular | 2 | 10 |
Nausea/vomiting | 1 | 5 |
Leukopenia | 2 | 10 |
Fatigue | 1 | 5 |
Anemia | 2 | 10 |
Lymphopenia | 2 | 10 |
Hemorrhage | 1 | 5 |
Rash | 1 | 5 |
Anorexia | 1 | 5 |
3.4. Efficacy Evaluation
3.5. VDR Polymorphism Evaluation
4. Discussion
Acknowledgments
Author Contributions
Conflicts of Interest
References
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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. https://doi.org/10.3390/jpm4040448
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. Journal of Personalized Medicine. 2014; 4(4):448-458. https://doi.org/10.3390/jpm4040448
Chicago/Turabian StylePettijohn, Erin, Brenda Martone, Alfred Rademaker, and Timothy Kuzel. 2014. "A Phase I Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma" Journal of Personalized Medicine 4, no. 4: 448-458. https://doi.org/10.3390/jpm4040448