A Phase 1, Multi-Center, Open-Label, Dose-Escalation Study of ¹³¹I-CLR1404 in Subjects with Relapsed or Refractory Advanced Solid Malignancies

REFERENCES

• Kaminski MS, Radford JA, Gregory SA, Leonard JP, Knox SJ, Kroll S, et al. Re-treatment with I-131 tositumomab in patients with non-Hodgkin's lymphoma who had previously responded to I-131 tositumomab. J Clin Oncol 2005;23(31):7985–7993.
   PubMed Web of Science ®Google Scholar
• Kaminski MS, Tuck M, Estes J, Kolstad A, Ross CW, Zasadny K, et al. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl J Med 2005;352(5):441–449.
   PubMed Web of Science ®Google Scholar
• Morschhauser F, Radford J, Van Hoof A, Vitolo U, Soubeyran P, Tilly H,et al. Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma. J Clin Oncol 2008;26(32):5156–5164.
   PubMed Web of Science ®Google Scholar
• Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3):213–223.
   PubMed Web of Science ®Google Scholar
• Brady D, Parker CC, O'Sullivan JM. Bone-targeting radiopharmaceuticals including radium-223. Cancer J 2013;19(1): 71–78.
   PubMed Web of Science ®Google Scholar
• Snyder F, Wood R. The occurrence and metabolism of alkyl and alk-1-enyl ethers of glycerol in transplantable rat and mouse tumors. Cancer Res 1968;28(5):972–978.
   PubMed Web of Science ®Google Scholar
• Snyder F, Wood R. Alkyl and alk-1-enyl ethers of glycerol in lipids from normal and neoplastic human tissues. Cancer Res 1969;29(1):251–257.
   PubMed Web of Science ®Google Scholar
• Soodsma JF, Piantadosi C, Snyder F. The biocleavage of alkyl glyceryl ethers in Morris hepatomas and other transplantable neoplasms. Cancer Res 1970;30(2):309–311.
   PubMed Web of Science ®Google Scholar
• Li YC, Park MJ, Ye SK, Kim CW, Kim YN. Elevated levels of cholesterol-rich lipid rafts in cancer cells are correlated with apoptosis sensitivity induced by cholesterol-depleting agents. Amer J Pathol 2006;168(4):1107–1118; quiz 1404–1105.
   PubMed Web of Science ®Google Scholar
• van der Luit AH, Budde M, Ruurs P, Verheij M, van Blitterswijk WJ. Alkyl-lysophospholipid accumulates in lipid rafts and induces apoptosis via raft-dependent endocytosis and inhibition of phosphatidylcholine synthesis. J Biol Chem 2002;277(42):39541–39547.
   PubMed Web of Science ®Google Scholar
• van der Luit AH, Vink SR, Klarenbeek JB, Perrissoud D, Solary E, Verheij M, et al. A new class of anticancer alkylphospholipids uses lipid rafts as membrane gateways to induce apoptosis in lymphoma cells. Mol Cancer Therapeut 2007;6(8):2337–2345.
   PubMed Web of Science ®Google Scholar
• Zaremberg V, Gajate C, Cacharro LM, Mollinedo F, McMaster CR. Cytotoxicity of an anti-cancer lysophospholipid through selective modification of lipid raft composition. J Biol Chem 2005;280(45):38047–38058.
   PubMed Web of Science ®Google Scholar
• Gajate C, Mollinedo F. Edelfosine and perifosine induce selective apoptosis in multiple myeloma by recruitment of death receptors and downstream signaling molecules into lipid rafts. Blood 2007;109(2):711–719.
   PubMed Web of Science ®Google Scholar
• Heczkova B, Slotte JP. Effect of anti-tumor ether lipids on ordered domains in model membranes. FEBS Lett 2006;580(10):2471–2476.
   PubMed Web of Science ®Google Scholar
• Ausili A, Torrecillas A, Aranda FJ, Mollinedo F, Gajate C, Corbalan-Garcia S, et al. Edelfosine is incorporated into rafts and alters their organization. J Phys Chem B 2008;112(37):11643–11654.
   PubMed Web of Science ®Google Scholar
• van Blitterswijk WJ, Verheij M. Anticancer alkylphospholipids: mechanisms of action, cellular sensitivity and resistance, and clinical prospects. Curr Pharmaceut Design 2008;14(21):2061–2074.
   PubMed Web of Science ®Google Scholar
• Patra SK. Dissecting lipid raft facilitated cell signaling pathways in cancer. Biochimica et Biophysica Acta 2008;1785(2):182–206.
   PubMed Web of Science ®Google Scholar
• Lasserre R, Guo XJ, Conchonaud F, Hamon Y, Hawchar O, Bernard AM, et al. Raft nanodomains contribute to Akt/PKB plasma membrane recruitment and activation. Nat Chem Biol 2008;4(9):538–547.
   PubMed Web of Science ®Google Scholar
• Carrasco MP, Jimenez-Lopez JM, Rios-Marco P, Segovia JL, Marco C. Disruption of cellular cholesterol transport and homeostasis as a novel mechanism of action of membrane-targeted alkylphospholipid analogues. British J Pharmacol 2010;160(2):355–366.
   PubMed Web of Science ®Google Scholar
• Mollinedo F, Gajate C. Lipid rafts and clusters of apoptotic signaling molecule-enriched rafts in cancer therapy. Future Oncol 2010;6(5):811–821.
   PubMed Web of Science ®Google Scholar
• Weichert JP, Clark PA, Kandela IK, Vaccaro AM, Clarke W, Longino MA, et al. Alkylphosphocholine analogs for broad-spectrum cancer imaging and therapy. Sci Transl Med 2014;6(240):240ra275.
   Web of Science ®Google Scholar
• Sawka AM, Thephamongkhol K, Brouwers M, Thabane L, Browman G, Gerstein HC. Clinical review 170: a systematic review and metaanalysis of the effectiveness of radioactive iodine remnant ablation for well-differentiated thyroid cancer. J Clin Endocrinol Metab 2004;89(8):3668–3676.
   PubMed Web of Science ®Google Scholar
• Mazzaferri EL, Kloos RT. Clinical review 128: current approaches to primary therapy for papillary and follicular thyroid cancer. J Clin Endocrinol Metab 2001;86(4):1447–1463.
   PubMed Web of Science ®Google Scholar
• Hay ID, Thompson GB, Grant CS, Bergstralh EJ, Dvorak CE, Gorman CA, et al. Papillary thyroid carcinoma managed at the Mayo Clinic during six decades (1940–1999): temporal trends in initial therapy and long-term outcome in 2444 consecutively treated patients. World J Surg 2002;26(8):879–885.
   PubMed Web of Science ®Google Scholar
• Morris DM, Boyle PJ, Stidley CA, Altobelli KK, Parnell T, Key C. Localized well-differentiated thyroid carcinoma: survival analysis of prognostic factors and (131)I therapy. Ann Surg Oncol 1998;5(4):329–337.
   PubMed Web of Science ®Google Scholar
• Varma VM, Beierwaltes WH, Nofal MM, Nishiyama RH, Copp JE. Treatment of thyroid cancer. Death rates after surgery and after surgery followed by sodium iodide I-131. Jama 1970;214(8):1437–1442.
   PubMed Web of Science ®Google Scholar
• Chow SM, Law SC, Mendenhall WM, Au SK, Chan PT, Leung TW, et al. Papillary thyroid carcinoma: prognostic factors and the role of radioiodine and external radiotherapy. Int J Radiat Oncol Biol Phys 2002;52(3):784–795.
   PubMed Web of Science ®Google Scholar
• Grudzinski JJ, Titz B, Kozak K, Clarke W, Allen E, Trembath L, et al. A phase 1 study of 131I-CLR1404 in patients with relapsed or refractory advanced solid tumors: dosimetry, biodistribution, pharmacokinetics, and safety. PLoS One 2014;9(11):e111652.
   PubMed Web of Science ®Google Scholar
• Stabin MG, Siegel JA. Physical models and dose factors for use in internal dose assessment. Health Phys 2003;85(3):294–310.
   PubMed Web of Science ®Google Scholar
• Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 2005;46(6):1023–1027.
   PubMed Web of Science ®Google Scholar
• Henzler T, Goldstraw P, Wenz F, Pirker R, Weder W, Apfaltrer P, et al. Perspectives of Novel Imaging Techniques for Staging, Therapy Response Assessment, and Monitoring of Surveillance in Lung Cancer: summary of the Dresden 2013 Post WCLC-IASLC State-of-the-Art Imaging Workshop. J Thorac Oncol 2015;10(2):237–249.
   PubMed Web of Science ®Google Scholar
• Stabin MG. Developments in the internal dosimetry of radiopharmaceuticals. Radiat Prot Dosimet 2003;105(1–4):575–580.
   PubMed Web of Science ®Google Scholar
• Deming DA, Maher ME, Leystra AA, Grudzinski JP, Clipson L, Albrecht DM, et al. Phospholipid ether analogs for the detection of colorectal tumors. PLoS One 2014;9(10):e109668.
   PubMed Web of Science ®Google Scholar
• Swanson KI, Clark PA, Zhang RR, Kandela IK, Farhoud M, Weichert JP, et al. Fluorescent cancer-selective alkylphosphocholine analogs for intraoperative glioma detection. Neurosurgery 2015;76(2):115–123; discussion 123–114.
   PubMed Web of Science ®Google Scholar
• Pinchuk AN, Rampy MA, Longino MA, Skinner RW, Gross MD, Weichert JP, et al. Synthesis and structure-activity relationship effects on the tumor avidity of radioiodinated phospholipid ether analogues. J Med Chem 2006;49(7):2155–2165.
   PubMed Web of Science ®Google Scholar