A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients

Bone Marrow Transplantation

Volumn 25, Issue 3, 2000, Pages 283-291

  List, A F ^a   Maziarz, R ^b   Stiff, P ^c   Jansen, J ^d   Liesveld, J ^e   Andrews, F ^k   Schuster, M ^f   Wolff, S ^g   Litzow, M ^h   Karanes, C ⁱ   Dahlberg, S ^c   Kirkhart, B ^j   Bianco, J A ^j   Singer, J W ^j  

^a UNIVERSITY OF ARIZONA   (United States)

^b UNIVERSITY OF OREGON   (United States)

^c LOYOLA UNIVERSITY CHICAGO   (United States)

^d METHODIST HOSPITAL   (United States)

^e STRONG MEMORIAL HOSPITAL   (United States)

^f WESTERN PENNSYLVANIA HOSPITAL   (United States)

^g VANDERBILT UNIVERSITY   (United States)

^h MAYO CLINIC   (United States)

ⁱ WAYNE STATE UNIVERSITY   (United States)

^j Cell Therapeutics Inc   (United States)

^k Arizona Cancer Center ^*

more..

Author keywords

Allogeneic bone marrow transplantation; Lisofylline

Indexed keywords

BUSULFAN; CARMUSTINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; ETOPOSIDE; LISOFYLLINE; MELPHALAN; METHYLPREDNISOLONE;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; ALLOGENIC BONE MARROW TRANSPLANTATION; ARTICLE; CANCER CHEMOTHERAPY; CANCER STAGING; CAUSE OF DEATH; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; FEMALE; GRAFT VERSUS HOST REACTION; HEADACHE; HLA MATCHING; HUMAN; HYPERTENSION; INFECTION COMPLICATION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MYELODYSPLASTIC SYNDROME; NAUSEA; NEUTROPHIL; NONHODGKIN LYMPHOMA; PARESTHESIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SEIZURE; SIBLING; SURVIVAL RATE; VOMITING; WHOLE BODY RADIATION;

EID: 0033975828     PISSN: 02683369     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bmt.1702114     Document Type: Article

References (40)

1. Holler E, Kolb HJ, Moller A et al. Increased serum levels of tumor necrosis factor alpha precede major complications of bone marrow transplantation. Blood 1990; 75: 1011-1016.
2. Nestel FP, Price KS, Seemayer TA, Lapp WS. Macrophage priming and lipopolysaccharide-triggered release of tumor necrosis factor alpha during graft-versus-host disease. J Exp Med 1992; 175: 405-413.
3. Sonis S, Lindquist L, Van Vugt A et al. Prevention of chemotherapy-induced ulcerative mucositis by transforming growth factor beta 3. Cancer Res 1994; 54: 1135-1138.
4. Maze R, Sherry B, Kwon BS et al. Myelosuppressive effects in vivo of purified recombinant murine macrophage inflammatory protein-1 alpha. J Immunol 1992; 149: 1004-1009.
5. Metcalf D. Hematopoietic regulators: redundancy or subtlety? Blood 1993; 82: 3515 (review).
6. Holler E, Kolb H, Hintermeier-Knabe R et al. Role of tumor necrosis factor alpha in acute graft-versus-host disease and complications following allogeneic hone marrow transplantation. Transplant Proc 1993; 25: 1234-1236.
7. Antin JH, Ferrara JL. Cytokine dysregulation and acute graft-versus-host disease. Blood 1992; 80: 2964-2968.
8. Anscher M, Peters W, Reisenbichler H et al. Transforming growth factor beta as a predictor of liver and lung fibrosis after autologous hone marrow transplantation for advanced breast cancer. New Engl J Med 1993; 328: 1592-1598.
9. Herve P, Flesch M, Tiberghien P et al. Phase I-II trial of a monoclonal anti-tumor necrosis factor alpha antibody for the treatment of refractory severe acute graft-versus-host disease. Blood 1992; 79: 3362-3368.
10. Hill GR, Crawford JM, Cooke KR et al. Total body irradiation and acute graft-versus-host disease: the role of gastrointestinal damage and inflammatory cytokines. Blood 1997; 90: 3204-3213.
11. Khan BV, Parthasarathy SS, Alexander RW, Medford RM. Modified low density lipoprotein and its constituents augment cytokine-activated vascular cell adhesion molecule-1 gene expression in human vascular endothelial cells. J Clin Invest 1995; 95: 1262-1270.
12. Marks JD, Marks CB, Luce JM et al. Plasma tumor necrosis factor in patients with septic shock. Mortality rate, incidence of adult respiratory distress syndrome, and effects of methylprednisolone administration. Am Rev Resp Dis 1999; 141: 94-97.
13. Riikonen P, Saarinen UM, Teppo AM et al. Cytokine and acute-phase reactant levels in serum of children with cancer admitted for fever and neutropenia. J Inject Dis 1992; 166: 432-436.
14. Steinmetz HT, Herbertz A, Bertram M, Diehl V. Increase in interleukin-6 serum level preceding fever in granulocytopenia and correlation with death from sepsis. J Infect Dis 1995; 171: 225-228.
15. Netea MG, Kullberg BJ, Blok WL et al. The role of hyperuricemia in the increased cytokine production after lipopolysaccharide challenge in neutropenic mice. Blood 1997; 89: 577-582.
16. Clarke E, Rice GC, Weeks RS et al. Lisofylline inhibits transforming growth factor beta release and enhances trilineage hematopoietic recovery after 5-fluorouracil treatment in mice. Cancer Res 1996; 56: 105-112.
17. Rice G, Rosen J, Weeks R et al. CT-1501R selectively inhibits induced inflammatory monokines in human whole blood ex vivo. Shock 1994; 1: 254-266.
18. de Vries P, Xu Z, Rice G, Singer J. In vivo therapy with lisofylline (LSF) in mice suppresses the ex vivo release of multilineage hematopoietic inhibitory activity induced by cancer chemotherapeutic agents (chemo) from murine splenocytes. Blood 1996; 88: 114b (Abstr.).
19. Wattanasirichaigoon S, Menconi MJ, Delude RL, Fink MP. Lisofylline ameliorates ilial ischemia/reperfusion-induced mucosal barrier dysfunction in rats. Dig Dis Weekly (in press).
20. Cicalese L, Yacoub W, Rogers J et al. Protective effect of lisofylline on bacterial translocation. Transplantation (in press).
21. Teicher B. Lisofylline as an adjuvant to high dose cytotoxic therapy. Int J Cancer (in press).
22. Abraham E, Bursten S, Shenkar R et al. Phosphatidic acid signaling mediates lung cytokine expression and lung inflammatory injury after hemorrhage in mice. J Exp Med 1995; 181: 569-575.
23. Waxman K, Daughters K, Aswani S, Rice G. Lisofylline decreases white cell adhesiveness and improves survival after experimental hemorrhagic shock. Crit Care Med 1996; 24: 1724-1728.
24. Hasegawa N, Oka Y, Nakayama M et al. The effects of post-treatment with lisofylline, a phosphatidic acid generation inhibitor, on sepsis-induced acute lung injury in pigs. Am J Respir Crit Care Med 1997; 155: 928-936.
25. List A, Shuster M, Blazar B et al. Phase I concentration-controlled, escalation trial of lisofylline (LSF) in patients (PTS) undergoing allogeneic hone marrow transplantation (BMT). Blood 1994; 84: 89a (Abstr.).
26. Klaus S, Coon M, Bright J et al. Lisofylline inhibits induction of EAE and Th1 differentiation by blocking IL-121 signaling and IFN-gamma secretion. Keystone Symposium on Molecular and Cellular Biology 1997; 4042 (Abstr.).
27. Bearman SI, Appelbaum FR, Buckner CD et al. Regimen-related toxicity in patients undergoing bone marrow transplantation. J Clin Oncol 1988; 6: 1562-1568.
28. Chao N, Schmidt G, Niland J et al. Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prophylaxis of acute graft-versus-host disease. New Engl J Med 1993; 329: 1225-1230.
29. Thomas ED, Storb R, Clift RA et al. Bone-marrow transplantation (second of two parts). New Engl J Med 1975; 292: 895-902.
30. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-459.
31. Klingemann HG, Storb R, Fefer A et al. Bone marrow transplantation in patients aged 45 years and older. Blood 1986; 67: 770-776.
32. Clift RA, Buckner CD, Appelbaum FR et al. Allogeneic marrow transplantation in patients with acute myeloid leukemia in first remission: a randomized trial of two irradiation regimens. Blood 1990; 76: 1867-1871.
33. McDonald GB, Hinds MS, Fisher LD et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med 1993; 118: 255-267.
34. Winston DJ, Ho WG, Champlin RE. Cytomegalovirus infections after allogeneic bone marrow transplantation. Rev Infect Dis 1990; 12 (Suppl): S776-S792.
35. Bow EJ, Loewen R, Cheang MS et al. Cytotoxic therapy-induced D-xylose malabsorption and invasive infection during remission-induction therapy for acute myeloid leukemia in adults. J Clin Oncol 1997; 15: 2254-2261.
36. Donnelly JP, Muus P, Schattenberg A et al. A scheme for daily monitoring of oral mucositis in allogeneic BMT recipients. Bone Marrow Transplant 1992; 9: 409-413.
37. Sonis ST, Singer JW, Busse P et al. Effects of lisofylline on radiotherapy-induced mucosal toxicity in hamsters. Dent Res (in press).
38. Singer J, List A, Federighi D et al. Serum hydroperoxy and hydroxyoctadecadienoic acids (HPODE and HODE) increase in response to total body irradiation (TBI) and are suppressed by lisofylline (LSF) in allogeneic BMT patients. Blood 1996; 88: 458a (Abstr.).
39. Clift R, Bianco J, Appelbaum F et al. A randomized controlled trial of pentoxifylline for the prevention of regimen-related toxicities in patients undergoing allogeneic marrow transplantation. Blood 1993; 82: 2025-2030.
40. Kalhs P, Lechner K, Stockschlader M et al. Pentoxifylline did not prevent transplant-related toxicity in 31 consecutive allogeneic bone marrow transplant recipients. Blood 1992; 80: 2683-2684 (letter).