A phase i study of nelfinavir concurrent with temozolomide and radiotherapy in patients with glioblastoma multiforme

Journal of Neuro-Oncology

Volumn 116, Issue 2, 2014, Pages 365-372

  Alonso Basanta, Michelle ^a   Fang, Penny ^a   Maity, Amit ^a   Hahn, Stephen M ^a   Lustig, Robert A ^a   Dorsey, Jay F ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Glioblastoma; Malignant glioma; Nelfinavir; Radiation therapy; Radiosensitizer

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTICONVULSIVE AGENT; ASPARTATE AMINOTRANSFERASE; HEMOGLOBIN; NELFINAVIR; TEMOZOLOMIDE;

ADJUVANT THERAPY; ADULT; AGED; AGITATION; ANOREXIA; ARTICLE; BEHAVIOR DISORDER; BLOATING; BLOOD TOXICITY; BRAIN SURGERY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SIZE; CANCER SURGERY; CHEMORADIOTHERAPY; CLINICAL ARTICLE; COHORT ANALYSIS; CONSTIPATION; DEEP VEIN THROMBOSIS; DEHYDRATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FECES INCONTINENCE; FEMALE; FLATULENCE; GLIOBLASTOMA; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPERKALEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; ISCHEMIA; LEUKOPENIA; LIVER TOXICITY; LOW DRUG DOSE; LUNG EMBOLISM; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; NAUSEA; PAIN; PATIENT MONITORING; PHASE 1 CLINICAL TRIAL; PHOTOPHOBIA; PRURITUS; RADIATION DOSE; SALIVARY GLAND DISEASE; SEIZURE; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VERY ELDERLY; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, ALKYLATING; BRAIN; COHORT STUDIES; DACARBAZINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GLIOBLASTOMA; HIV PROTEASE INHIBITORS; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; NELFINAVIR; OUTCOME ASSESSMENT (HEALTH CARE); TIME FACTORS;

EID: 84893666659     PISSN: 0167594X     EISSN: 15737373     Source Type: Journal    
DOI: 10.1007/s11060-013-1303-3     Document Type: Article

References (23)

1. Stupp R, Mason WP, Van Den Bent MJ et al (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352:987-996
2. Nishikawa R, Sugiyama T, Narita Y, Fumari F, Cavenee WK, Matsutani M (2004) Immunohistochemical analysis of the mutant epidermal growth factor, deltaEGFR, in glioblastoma. Brain Tumor Pathol 21(2):53-56
3. Moldvay J, Scheid P, Wild P, Nabil K, Siat J, Borrelly J et al (2000) Predictive survival markers in patients with surgically resected non-small cell lung carcinoma. Clin Cancer Res 6(3):1125-1134
4. Schneider PM, Praeuer HW, Stoeltzing O, Boehm J, Manning J, Metzger R, Fink U, Wegerer S, Hoelscher AH, Roth JA (2000) Multiple molecular marker testing (p53, C-Ki-ras, c-erbB-2) improves estimation of prognosis in potentially curative resected non-small cell lung cancer. Br J Cancer 83(4):473-479
5. Harari PM, Huang SM (2001) Head and neck cancer as a clinical model for molecular targeting of therapy: combining EGFR blockade with radiation. Int J Radiat Oncol Biol Phys 49(2):427-433
6. McKenna WG, Weiss MC, Endlich B, Ling CC, Bakanauskas VJ, Kelsten ML, Muschel RJ (1990) Synergistic effect of the v-myc oncogene with H-ras on radioresistance. Cancer Res 50(1):97-102
7. Bernhard EJ, Stanbridge EJ, Gupta S, Gupta AK, Soto D, Bakanauskas VJ, Cerniglia GJ, Muschel RJ, McKenna WG (2000) Direct evidence for the contribution of activated N-ras and Kras oncogenes to increased intrinsic radiation resistance in human tumor cell lines. Cancer Res 60(23):6597-6600
8. Gupta AK, Bakanauskas VJ, Cerniglia GJ, Cheng Y, Bernhard EJ, Muschel RJ, McKenna WG (2001) The Ras radiation resistance pathway. Cancer Res 61(10):4278-4282
9. Gupta AK, McKenna WG, Weber CN, Feldman MD, Goldsmith JD, Mick R, Machtay M et al (2002) Local recurrence in head and neck cancer: relationship to radiation resistance and signal transduction. Clin Cancer Res 8(3):885-892
10. Gupta AK, Cerniglia GJ, Mick R, Ahmed MS, Bakanauskas VJ, Muschel RJ, McKenna WG (2003) Radiation sensitization of human cancer cells in vivo by inhibiting the activity of PI3K using LY294002. Int J Radiat Oncol Biol Phys 56(3):846-853
11. Grana TM, Rusyn EV, Zhou H, Sartor CI, Cox AD (2002) Ras mediates radioresistance through both phosphatidylinositol 3-kinase-dependent and Raf-dependent but mitogen-activated protein kinase/extracellular signal-regulated kinase kinase-independent signaling pathways. Cancer Res 62(14):4142-4150
12. Carr A, Samaras K, Thorisdottir A, Kaufmann GR, Chisholm DJ, Cooper DA (1999) Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet 353(9170):2093-2099
13. Powderly WG (2002) Long-term exposure to lifelong therapies. J Acquir Immune Defic Syndr 29(Suppl 1):S28-S40
14. Bae SS, Cho H, Mu J, Birnbaum MJ (2003) Isoform-specific regulation of insulin-dependent glucose uptake by Akt/protein kinase B. J Biol Chem 278(49):49530-49536
15. Cross DA, Watt PW, Shaw M, Downes CP, van der Kaay J, Holder JC, Cohen P (1997) Insulin activates protein kinase B, inhibits glycogen synthase kinase-3 and activates glycogen synthase by rapamycin-insensitive pathways in skeletal muscle and adipose tissue. FEBS Lett 406(1-2):211-215
16. Saag MS, Tebas P, Sension M, Conant M, Myers R, Chapman SK, Anderson R (2001) Randomized, double-blind comparison of two nelfinavir doses plus nucleosides in HIV-infected patients (Agouron study 511). AIDS 15(15):1971-1978
17. Stadler RF, Gregorcyk SG, Euhus DM, Place RJ, Huber PH, Simmang CL (2004) Outcome of HIV-infected patients with invasive squamous-cell carcinoma of the anal canal in the era of highly active antiretroviral therapy. Dis Colon Rectum 47(8):1305-1309
18. Thomson Healthcare (2004) Physicians' desk reference, 58th edn. Thomson PDR, Montvale, NJ
19. Jiang Z, Pore N, Cerniglia GJ, Mick R, Georgescu M, Bernhard EJ, Hahn SM, Gupta AK, Maity A (2007) Phosphatase and tensin homologue deficiency in glioblastoma confers resistance to radiation and temozolomide that is reversed by the protease inhibitor nelfinavir. Cancer Res 67(9):4467-4473
20. James JS (1997) Nelfinavir (Viracept) approved: fourth protease inhibitor available. AIDS Treat News 267:1-2
21. Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG (2004) The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy - naïve HIV-1-infected patients. J Acquir Immune Defic Syndr 35(1):22-32
22. Chang EL, Akyurek S, Avalos T, Rebueno N, Spicer C, Garcia J, Famiglietti R et al (2007) Evaluation of peritumoral edema in the delineation of radiotherapy clinical target volumes for glioblastoma. Int J Radiat Oncol Biol Phys 68(1):144-150
23. Milano MT, Okunieff P, Donatello RS, Mohile NA, Sul J, Walter KA, Korones DN (2010) Patterns and timing of recurrence after temozolomide-based chemoradiation for glioblastoma. Int J Radiat Oncol Biol Phys 78(3):1147-1155