Phase I study of bryostatin 1 and fludarabine in patients with chronic lymphocytic leukemia and indolent (non-Hodgkin's) lymphoma

Clinical Cancer Research

Volumn 12, Issue 19, 2006, Pages 5809-5816

  Roberts, John D ^a   Smith, Mitchell R ^b   Feldman, Eric J ^c   Cragg, Louise ^d   Millenson, Michael M ^b   Roboz, Gail J ^c   Honeycutt, Connie ^a   Thune, Rose ^a   Padavic Shaller, Kristin ^b   Carter, W Hans ^a   Ramakrishnan, Viswanathan ^a   Murgo, Anthony J ^e   Grant, Steven ^a,f  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b FOX CHASE CANCER CENTER   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d Mercy Cancer Center   (United States)

^e NATIONAL CANCER INSTITUTE   (United States)

^f VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BRYOSTATIN 1; COTRIMOXAZOLE; FLUDARABINE; HEMOGLOBIN; NSC 339555; PROTEIN KINASE C;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD TOXICITY; BLURRED VISION; BONE MARROW SUPPRESSION; CATARACT; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DOWN REGULATION; DRUG ACTIVITY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HEART MUSCLE ISCHEMIA; HUMAN; HUMAN CELL; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPERURICEMIA; INFECTION; INSOMNIA; LABORATORY TEST; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SIDE EFFECT; SYNCOPE; TUMOR LYSIS SYNDROME; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC; LYMPHOMA, NON-HODGKIN; MACROLIDES; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; SURVIVAL RATE; VIDARABINE;

EID: 33750313170     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-2730     Document Type: Article

References (50)

1. Mutter R, Wills M. Chemistry and clinical biology of the bryostatins. Bioorg Med Chem 2000;8:1841-60.
2. Grant S, Traylor R, Bhalla K, McCrady C, Pettit CR. Effect of a combined exposure to cytosine arabinoside, bryostatin 1, and recombinant granulocyte-macrophage colony-stimulating factor on the clonogenic growth in vitro of normal and leukemic human hematopoietic progenitor cells. Leukemia 1992;6:432-9.
3. Hornung RL, Pearson, JW, Beckwith M, Longo D. Preclinical evaluation of bryostatin as an anticancer agent against several murine tumor cell lines: in vitro versus in vivo activity. Cancer Res 1992;52:101-7.
4. Kennedy MJ, Prestigiacomo LJ, Tyler G, May WS, Davidson NE. Differential effects of bryostatin 1 and phorbol ester on human breast cancer cell lines. Cancer Res 1992;52:1278-83.
5. Grant S, Pettit GR, Howe C, McCrady C. Effect of the protein kinase C activating agent bryostatin 1 on the clonagenic response of leukemic blast progenitors to recombinant granulocyte-macrophage colony-stimulating factor. Leukemia 1991;5:392-8.
6. Kortmansky J, Schwartz GK. Bryostatin-1: a novel PKC inhibitor in clinical development. Cancer Invest 2003;21:924-36.
7. May WS, Sharkis SJ, Esa AH, et al. Antineoplastic bryostatins are multipotential stimulators of human hematopoietic progenitor cells. Proc Natl Acad Sci U S A 1987;84:8483-7.
8. Drexler HG, Gignac SM, Jones RA, Scott CS, Pettit GR, Hoffbrand AV. Bryostatin 1 induces differentiation of B-chronic lymphocytic leukemia cells. Blood 1989;74:1747-57.
9. Berkow RL, Kraft AS. Bryostatin, a non-phorbol macrocyclic lactone, activates intact human polymorphonuclear leukocytes and binds to the phorbol receptor. Biochem Biophys Res Commun 1985;131:1109-16.
10. Bosco MC, Rottschafer S, Taylor LS, Ortaldo JR, Longo DL, Espinoza-Delgado I. The antineoplastic agent bryostatin-1 induces proinflammatory cytokine production in human monocytes: synergy with interleukin-2 and modulation of interleukin-2Rγ chain expression. Blood 1997;89:3402-11.
11. Hess AD, Silanskis MK, Esa AH, Pettit GR, May WS. Activation of human T lymphocytes by bryostatin. J Immunol 1988;141:3263-9.
12. Tallant EA, Smith JB, Wallace RW. Bryostatins mimic the effects of phorbol esters in intact human platelets. Biochim Biophys Acta 1987;929:40-6.
13. McCrady CW, Staniswalis J, Pettit GR, Howe C, Grant S. Effect of pharmacologic manipulation of protein kinase C by phorbol dibutyrate and bryostatin 1on the clonogenic response of human granulocyte-macrophage progenitors to recombinant GM-CSF. Br J Haematol 1991;77:5-15.
14. Li F, Grant S, Pettit GR, McCrady CW. Bryostatin 1 modulates the proliferation and lineage commitment of human myeloid progenitor cells exposed to recombinant interleukin-3 and recombinant granulocyte-macrophage colony-stimulating factor. Blood 1992;80:2495-502.
15. Bhatia U, Traganos F, Darzynkiewicz Z. Induction of cell differentiation potentiates apoptosis triggered by prior exposure to DNA-damaging drugs. Cell Growth Differ 1995;6:937-44.
16. Vrana JA, Wang Z, Rao AS, et al. Induction of apoptosis and differentiation by fludarabine in human leukemia cells (U937): interactions with the macrocyctic lactone bryostatin 1, Leukemia 1999;13:1046-55.
17. Mohammad RM, Katato K, Almatchy VP, et al. Sequential treatment of human chronic lymphocytic leukemia with bryostatin 1 followed by 2- chlorodeoxyadenosine: preclinical studies. Clin Cancer Res 1998;4:445-53.
18. Mohammad RM, Limvarapuss C, Hamdy N, et al. Treatment of a de novo fludarabine resistant CLL-xenograft model with bryostatin 1followed by fludarabine. Int J Oncol 1999;14:945-50.
19. Goekjian PG, Jirousek MR. Protein kinase C inhibitors as novel anticancer drugs. Expert Opin Investig Drugs 2001;10:2117-40.
20. Lee HW, Smith L, Pettit GR, Smith JB. Bryostatin 1 and phorbol ester down-modulate protein kinase C-α and -ε via the ubiquitin/proteasome pathway in human fibroblasts. Mol Pharmacol 1997;51:439-47.
21. Al-Katib AM, Smith MR, Kamanda WS, et al. Bryostatin 1 down-regulates mdr1 and potentiates vincristine toxicity in diffuse large cell lymphoma xenografts. Clin Cancer Res 1998;4:1305-14.
22. Curiel RE, Garcia CS, Farooq L, Aguero MF, Espinoza-Delgado I. Bryostatin-1 and IL-2 synergize to induce IFN-γ expression in human peripheral blood T cells: implications for cancer immunotherapy. J Immunol 2001;167:4828-37.
23. Steube KG, Drexler HG. The protein kinase C activator bryostatin-1 induces the rapid release of TNFα from MONO-MAC-6 cells. Biochem Biophys Res Commun 1995;214:1197-203.
24. Wall NR, Mohammad RM, Reddy KB, Al-Katib AM. Bryostatin-1 induces ubiquitination and proteasome degradation of Bcl-2 in the human acute lymphoblastic leukemia cell line, Reh. Int J Mol Med 2000;5:165-71.
25. Prendiville J, Crowther D, Thatcher N, et al. A phase I study of intravenous bryostatin 1 in patients with advanced cancer. Br J Cancer 1993;68:418-24.
26. Philip PA, Rea D, Thavasu P et al. Phase I study of bryostatin 1: assessment of interleukin 6 and tumor necrosis factor α induction in vivo. The Cancer Research Campaign Phase I Committee. J Natl Cancer Inst 1993;85:1812-8.
27. Jayson GC, Crowther D, Prendiville J, et al. A phase I trial of bryostatin 1 in patients with advanced malignancy using a 24 hour intravenous infusion. Br J Cancer 1995;72:461-8.
28. Varterasian ML, Mohammad RM, Eilender DS, et al. Phase I study of bryostatin 1 in patients with relapsed non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Clin Oncol 1998;16:56-62.
29. Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood 1975;46:219-34.
30. Harris NL, Jaffe ES, Stein H, et al. A revised Europe an-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood 1994;84:1361.
31. Anaissie EJ, Kontoyiannis DP, O'Brien S, et al. Infections in patients with chronic lymphocytic leukemia treated with fludarabine. Ann Intern Med 1998;129:559-66
32. Cheson BD, Bennett JM, Rai KR, et al. Guidelines for clinical protocols for chronic lymphocytic leukemia: recommendations of the National Cancer Institutesponsored working group. Am J Hematol 1988;29:152-63.
33. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 1997;89:1138-47.
34. Jarvis WD, Fornari FA, Kolesnick RN, Browning JL, Gewirtz DA, Grant S. Attenuation of ceramide-induced apoptosis in human myeloid leukemia cells by diglyceride. J Biol Chem 1994;269:31685-92.
35. Jarvis D, Povirk L, Turner A, Traylor R, Grant S. Induction of DNA fragmentation and cell death in (HL-60) human promyelocytic leukemia cells by pharmacologic inhibitors of protein kinase C. Cancer Res 1994;54:1707-14.
36. Keating MJ, Kantarjian H, Talpaz M, et al. Fludarabine: a new agent with major activity against chronic lymphocytic leukemia. Blood 1989;74:19-25.
37. O'Brien S, Kantarjian H, Beran M, et al. Results of fludarabine and prednisone therapy in 264 patients with chronic lymphocytic leukemia with multivariate analysis-derived prognostic model for response to treatment. Blood 1993;82:1695-700.
38. Puccio CA, Mittelman A, Lichtman SM, et al. A loading dose/continuous infusion schedule of fludarabine phosphate in chronic lymphocytic leukemia. J Clin Oncol 1991;9:1562-9.
39. Solal-Celigny P, Brice P, Brousse N, et al. Phase II trial of fludarabine monophosphate as first-line treatment in patients with advanced follicular lymphoma a multicenter study by the Groupe d'Etude des Lym phomesde l'Adulte. J Clin Oncol 1996;14:514-9
40. Redman JR, Cabanillas F, Velasquez WS, et al. Phase II trial of fludarabine phosphate in lymphoma: an effective new agent in low-grade lymphoma. J Clin Oncol 1992;10:790-4.
41. Whelan JS, Davis CL, Rule S, et al. Fludarabine phosphate for the treatment of low grade lymphoid malignancy. Br J Cancer 1991;64:120-3.
42. Dowlati A, Lazarus HM, Hartman P, et al. Phase I and correlative study of combination bryostatin 1 and vincristine in relapsed B-cell malignancies. Clin Cancer Res 2003;9:5929-35.
43. Kitada S, Zapata JM, Andreeff M, Reed JC. Bryostatin and CD40-ligand enhance apoptosis resistance and induce expression of cell survival genes in B-cell chronic lymphocytic leukaemia. Br J Haematol 1999;106:995-1004.
44. Grant S, Roberts J, Poplin E, et al. Phase Ib trial of bryostatin 1 in patients with refractory malignancies. Clin Cancer Res 1998;4:611-8.
45. Hofmann J. Protein kinase C isozymes as potential targets for anticancer therapy. Curr Cancer Drug Targets 2004;4:125-46.
46. Zhao M, Rudek MA, He P, Smith BD, Baker SD. Validation and implementation of a method for determination of bryostatin 1 in human plasma by using liquid chromatography/tandem mass spectrometry. Anal Biochem 2005;337:143-8.
47. Savage DG, Cohen NS, Hesdorffer CS, et al. Combined fludarabine and rituximab for low grade lymphoma and chronic lymphocytic leukemia. Leuk Lymphoma 2003;44:477-81.
48. Hiddemann W, Forstpointner R, Kneba M, et al. The addition of rituximab to combination chemotherapy with CHOP has a long lasting impact on subsequent treatment in remission in follicular lymphoma but not in mantle cell lymphoma: results of two prospective randomized studies of the German Low Grade Lymphoma Study Group (GLSG) [abstract 161]. Blood 2004;104:50a.
49. Smith MR. Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance. Oncogene 2003;22:7359-68.
50. Wojciechowski W, Li H, Marshall S, DellAgnola C, Espinoza-Delgado I. Enhanced expression of CD20 in human tumor B cells is controlled through ERK-dependent mechanisms. J Immunol 2005;174:7859-68.