A phase 1-2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: Study protocol of [ISRCTN45828668]

BMC Cancer

Volumn 6, Issue , 2006, Pages

  Robe, Pierre A ^a   Martin, Didier ^a   Albert, Adelin ^a   Deprez, Manuel ^a   Chariot, Alain ^a   Bours, Vincent ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CARMUSTINE; LOMUSTINE; SALAZOSULFAPYRIDINE; TEMOZOLOMIDE; NONSTEROID ANTIINFLAMMATORY AGENT;

ADULT; ARTICLE; CANCER GRADING; CANCER REGRESSION; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; GLIOBLASTOMA; HUMAN; MAXIMUM PERMISSIBLE DOSE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; AGED; BRAIN TUMOR; DISEASE COURSE; FEMALE; GLIOMA; MALE; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BRAIN NEOPLASMS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; GLIOMA; HUMANS; MALE; MIDDLE AGED; PROGNOSIS; PROSPECTIVE STUDIES; SULFASALAZINE; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33144461875     PISSN: 14712407     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-6-29     Document Type: Article

References (17)

1. Black PM, Alexander E, Martin C, Moriarty T, Nabavi A, Wong TZ, Schwartz RB, Jolesz F: Craniotomy for tumor treatment in an intraolperative magnetic resonance imaging unit. Neurosurgery 1999, 45(3):423-31; discussion 431-3.
2. Shrieve DC, Alexander E, Black PM, Wen PY, Fine HA, Kooy HM, Loeffler JS: Treatment of patients with primary glioblastoma multiforme with standard postoperative radiotherapy and radiosurgical boost: prognostic factors and long-term outcome. J Neurosurg 1999, 90(1):72-77.
3. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO: Radiotherapy plus concomitant and adjuvant temozolomidle for glioblastoma. N Engl J Med 2005, 352(10):987-996.
4. Ohgaki H, Kleihues P: Population-based studies on incidence, survival rates, and genetic alterations in astrocytic and oilgodendroglial gliomas. J Neuropothol Exp Neural 2005, 64(6):479-489.
5. Ansari SA, Safak M, Del Valle L, Enam S, Amini S, Khalili K; Cell cycle regulation of NF-kappa b-binding activity in cells from human glioblastomas. Exp Cell Res 2001, 265(2):221-233.
6. Robe PA, Bentires-Alj M, Bonif M, Rogister B, Deprez M, Haddada H, Khac MT, Jolois O, Erkmen K, Merville MIP, Black PM, Bours V: In vitro and in vivo activity of the nuclear factor-kappaB inhibitor sulfasalazine in human glioblastomas. Clin Cancer Res 2004, 10(16):5595-5603.
7. Yin D, Zhou H, Kumagai T, Liu G, Ong JM, Black KL, Koeffler HP: Proteasome inhibitor PS-341 causes cell growth arrest and apoptosis in human glioblastorna multiforme (GBM). Oncogene 2005, 24(3):344-354.
8. Wang H, Wang H, Zhang W, Huang HJ, Liao WS, Fuller GN: Analysis of the activation status of Akt, NFkappaB, and Stat3 in human diffuse glionnas. Lob Invest 2004, 84(8):941-951.
9. Bours V, Bentires-Alj M, Hellin AC, Viatour P, Robe P, Delhalle S, Benoit V, Merville MP. Nuclear factor-kappa B, cancer, and apoptosis. Biochem Pharmocol 2000, 60(8):1085-1089.
10. Bentires-Alj M, Barbu V, Fillet M, Chariot A, Relic B, Jacobs N, Gielen J, Merville MP, Bours V: NF-kappaB transcription factor induces drug resistance through MDRI expression in cancer cells. Oncogene 2003, 22(1):90-97.
11. Rayet B, Gelinas C: Aberrant rel/nfkb genes and activity in human cancer. Oncogene 1999, 18(49):6938-6947.
12. Anderson KC: Moving disease biology from the laboratory to the clinic. Semin Oncol 2002, 29(6 Suppi 17):17-20.
13. Kane RC, Bross PF, Farrell AT, Pazdur R. Velcade: U.S. FDA approval for theent of multiple myeloma progressing on prior therapy. Oncologist 2003, 8(6):508-513.
14. Rains CP Noble S, Faulds D: Sulfasalazine. A review of its pharmacological properties and therapeutic efficacy in the treatment of rheumatoid arthritis. Drugs 1995, 50(1): 137-156.
15. Wahl C, Liptay S, Adler G, Schmid RM: Sulfasalazine: a potent and specific inhibitor of nuclear factor kappa B. J Clin Invest 1998, 101(5):1163-1174.
16. Weber CK, Liptay S, Wirth T, Adler G, Schmid RM: Suppression of NF-kappaB activity by sulfasalazine is mediated by direct inhibition of IkappaB kinases alpha and beta. Gastroenterology 2000, 119(5): 1209-1218.
17. Macdonald DR, Cascino TL, Schold SCJ, Cairncross JG: Response criteria for phase 11 studies of supratentorial malignant glioma. J Clin Oncol 1990, 8(7):1277-1280.