A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse

Leukemia Research

Volumn 30, Issue 7, 2006, Pages 777-783

  Moore, Joseph ^a   Seiter, Karen ^b   Kolitz, Jonathan ^c   Stock, Wendy ^d   Giles, Francis ^e   Kalaycio, Matt ^f   Zenk, David ^g   Marcucci, Guido ^h  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b NEW YORK MEDICAL COLLEGE   (United States)

^c NORTH SHORE UNIVERSITY HOSPITAL   (United States)

^d UNIVERSITY OF CHICAGO   (United States)

^e UNIVERSITY OF TEXAS   (United States)

^f LERNER RESEARCH INSTITUTE   (United States)

^g Iowa Blood and Cancer Care   (United States)

^h OHIO STATE UNIVERSITY   (United States)

Author keywords

Acute myeloid leukemia; Bcl 2 antisense; G3139; Genasense ; Oblimersen sodium

Indexed keywords

CD33 ANTIGEN; GEMTUZUMAB OZOGAMICIN; OBLIMERSEN;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; AGED; ANEMIA; ANOREXIA; ARTICLE; BACTEREMIA; CANCER PATIENT; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPNEA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; HYPOTENSION; INSOMNIA; LEG EDEMA; LEUKEMIA RELAPSE; MALE; MEDICAL ASSESSMENT; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PAIN; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RESPIRATORY FAILURE; RIGOR; SAMPLE SIZE; SENESCENCE; SEPSIS; SURVIVAL RATE; SURVIVAL TIME; THERAPY EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; URINARY TRACT INFECTION;

ACUTE DISEASE; AGED; AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYTOGENETIC ANALYSIS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; LEUKEMIA, MYELOID; MALE; MAXIMUM TOLERATED DOSE; RECURRENCE; RISK FACTORS; SURVIVAL RATE; THIONUCLEOTIDES; TREATMENT OUTCOME;

EID: 33744552602     PISSN: 01452126     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.leukres.2005.10.025     Document Type: Article

References (24)

1. Estey E.H. How I treat older patients with AML. Blood 96 (2000) 1670-1673
2. Berger M.S., Leopold L.H., Dowell J.A., Korth-Bradley J.M., and Sherman M.L. Licensure of gemtuzumab ozogamicin for the treatment of selected patients 60 years of age or older with acute myeloid leukemia in first relapse. Invest New Drugs 20 (2002) 395-406
3. Bross P.F., Beitz J., Chen G., Chen X.H., Duffy E., Kieffer L., et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res 7 (2001) 1490-1496
4. Larson R.A., Boogaerts M., Estey E., Karanes C., Stadtmauer E.A., Sievers E.L., et al. Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin). Leukemia 16 (2002) 1627-1636
5. Karakas T., Maurer U., Weidmann E., Miething C.C., Hoelzer D., and Bergmann L. High expression of bcl-2 mRNA as a determinant of poor prognosis in acute myeloid leukemia. Ann Oncol 9 (1998) 159-165
6. Reed J.C. Apoptosis-targeted therapies for cancer. Cancer Cell 3 (2003) 17-22
7. Wu G.S., and El-Deiry W.S. Apoptotic death of tumor cells correlates with chemosensitivity, independent of p53 or bcl-2. Clin Cancer Res 2 (1996) 623-633
8. Reed J.C. Dysregulation of apoptosis in cancer. J Clin Oncol 17 (1999) 2941-2953
9. Cory S., Huang D.C., and Adams J.M. The Bcl-2 family: roles in cell survival and oncogenesis. Oncogene 22 (2003) 8590-8607
10. Adams J.M. Ways of dying: multiple pathways to apoptosis. Genes Dev 17 (2003) 2481-2495
11. Kim R., Tanabe K., Uchida Y., Emi M., Inoue H., and Toge T. Current status of the molecular mechanisms of anticancer drug-induced apoptosis. The contribution of molecular-level analysis to cancer chemotherapy. Cancer Chemother Pharmacol 50 (2002) 343-352
12. Makin G. Targeting apoptosis in cancer chemotherapy. Expert Opin Ther Targets 6 (2002) 73-84
13. Klasa R.J., Gillum A.M., Klem R.E., and Frankel S.R. Oblimersen Bcl-2 antisense: facilitating apoptosis in anticancer treatment. Antisense Nucleic Acid Drug Dev 12 (2002) 193-213
14. Khodadoust M., Konopleva M., Leysath C., Frankel S., Giles F., and Andreeff M. Bcl-2 Antisense oligodeoxynucleotide (Genasense) enhances gemtuzumab ozogamicin (Mylotarg)-induced cytotoxicity in acute myeloid leukemia. Blood 98 (2001) 102a Abstract 429
15. Sievers E.L., Larson R.A., Stadtmauer E.A., Estey E., Lowenberg B., Dombret H., et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 19 (2001) 3244-3254
16. Bickel P.J., and Doksum K.A. Mathematical Statistics (1977), Holden-Day, San Francisco
17. Garrido S.M., Cooper J.J., Appelbaum F.R., Willman C.L., Kopecky K., and Banker D.E. Blasts from elderly acute myeloid leukemia patients are characterized by low levels of culture- and drug-induced apoptosis. Leuk Res 25 (2001) 23-32
18. Vey N., Keating M., Giles F., Cortes J., Beran M., and Estey E. Effect of complete remission on survival in patients with acute myelogenous leukemia receiving first salvage therapy. Blood 93 (1999) 3149-3150
19. Marcucci G., Byrd J.C., Dai G., Klisovic M.I., Kourlas P.J., Young D.C., et al. Phase 1 and pharmacodynamic studies of G3139, a Bcl-2 antisense oligonucleotide, in combination with chemotherapy in refractory or relapsed acute leukemia. Blood 101 (2003) 425-432
20. Marcucci G., Dai G., Klisovic M.I., Shen T., Liu S., Sher D.A., et al. Pharmacologic and biologic assessment of Genasense (GNS, oblimersen sodium), a pro-apoptotic to Bcl-2 oligonucleotide, in combination with daunorubicin and cytarabine: a Phase I study in previously untreated elderly acute myeloid leukemia (AML). Blood 102 (2003) 874a [abstract 1398]
21. Marcucci G., Stock W., Dai G., Klisovic R.B., Liu S., Klisovic M.I., et al. Phase I study of oblimersen sodium, an antisense to Bcl-2, in untreated older patients with acute myeloid leukemia: pharmacokinetics, pharmacodynamics and clinical activity. J Clin Oncol 23 (2005) 3404-3410
22. Kirkwood J.M., Bedekian A.Y., Millward M.J., Conry R.M., Gore M.E., Pehamberger H.E., et al. Long-term survival results of a randomized multinational Phase 3 trial of dacarbazine (DTIC) with or without Bcl-2 antisense (oblimersen sodium) in patients (pts) with advanced malignant melanoma (MM). J Clin Oncol 23 (2005) 711s [abstract 7506]
23. Rai K.R., Moor J.O., Boyd T.E., Laratt L.M., Golenkov A.K., Koziner B., et al. Phase 3 randomized trial of fludarabine/cyclophosphamide chemotherapy with or without oblimersen sodium (Bcl-2 antisense; genasense; G3139) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Blood 104 (2004) 100a [abstract 338]
24. Leith C.P., Kopeck K.J., Godwin J., McConnell T., Slovak M.L., Chen I.-M., et al. Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A southwest oncology group study. Blood 89 (1997) 3323-3329