Phase I study of mitoxantrone plus etoposide with multidrug blockade by SDZ PSC-833 in relapsed or refractory acute myelogenous leukemia

Journal of Clinical Oncology

Volumn 15, Issue 5, 1997, Pages 1796-1802

  Kornblau, S M ^a   Estey, E ^a   Madden, T ^a   Tran, H T ^a   Zhao, S ^a   Consoli, U ^a   Snell, V ^a   Sanchez Williams, G ^a   Kantarjian, H ^a   Keating, M ^a   Newman, R A ^a   Andreeff, M ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTARABINE; ETOPOSIDE; FLUDARABINE; GLYCOPROTEIN P; GRANULOCYTE COLONY STIMULATING FACTOR; IDARUBICIN; MITOXANTRONE; VALSPODAR;

ACUTE GRANULOCYTIC LEUKEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; HUMAN; HUMAN CELL; INTRAVENOUS DRUG ADMINISTRATION; MUCOSA INFLAMMATION; MULTIDRUG RESISTANCE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0030951875     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.5.1796     Document Type: Article

References (37)

1. Yuen AR, Sikic BI: Multidrug resistance in lymphomas. J Clin Oncol 12:2453-2459, 1996
2. Holzmayer TA, Hilsenbeck S, VonHoff DD, et al: Clinical correlates of MDR1 (P-glycoprotein) gene expression in ovarian and small-cell lung carcinomas. J Natl Cancer Inst 455:152-162, 1992
3. Kaye SB: P-glycoprotein (P-gp) and drug resistance - Time for reappraisal? Br J Cancer 67:641-643, 1993
4. Fisher GA, Sikic BI: Clinical studies with modulators of multidrug resistance. Hematol Oncol Clin North Am 9:235-503, 1995
5. Miller TP, Grogan TM, Dalton WS, et al: P-glycoprotein expression in malignant lymphoma and reversal of clinical drug resistance with chemotherapy plus high-dose verapamil. J Clin Oncol 9:17-24, 1991
6. Cornelissen JJ, Sonneveld P, Schoester M, et al: MDR-1 expression and response to vincristine, doxorubicin, and dexamethasone chemotherapy in multiple myeloma refractory to alkylating agents. J Clin Oncol 12:115-119, 1994
7. Maslak P, Hegewisch-Becker S, Godfrey L, et al: Flow cytometric determination of the multidrug resistance phenotype in acute leukemia. Cytometry 17:84-93, 1994
8. Andreeff M, Hegewisch-Becker S, Rehermann B, et al: Flow cytometric determination of p-glycoprotein in acute leukemia. Proc Am Assoc Cancer Res 31:1134, 1990 (abstr)
9. Redner A, Hegewisch S, Haimi J, et al: A study of multidrug resistant and cell kinetics in a child with near-haploid acute lymphoblastic leukemia. Leuk Res 14:771-777, 1990
10. Marie J, Zittoun R, Sikic BI: Multidrug resistance (mdr1) gene expression in adult acute leukemias: Correlation with treatment outcome and in vitro drug sensitivity. Blood 78:586-592, 1991
11. Hunault M, Zhou D, Ramon S, et al: MDR expression in acute myeloid leukemia (AML): Major prognosis significance in multivariate analysis. Blood 86:269a, 1995 (suppl 1, abstr)
12. Campos L, Guyotat D, Archimbaud E, et al: Clinical significance of multidrug resistance P-glycoprotein expression on acute nonlymphoblastic leukemia cells at diagnosis. Blood 79:473-476, 1992
13. Leith C, Kopecky K, Chen I, et al: MDR1 expression is highly predictive for achievement of complete remission (CR) in acute myeloid leukemia (AML) in the elderly: A Southwest Oncology Group Study. Blood 86:269a, 1995 (suppl 1, abstr)
14. Holmes JA, West RR: The effect of MDR-1 gene expression on outcome in acute myeloblastic leukaemia. Br J Cancer 69:382-384, 1994
15. Berman E, McBride M, Lin S, et al: Phase I trial of high-dose tamoxifen as a modulator of drug resistance in combination with daunorubicin in patients with relapsed or refractory acute leukemia. Leukemia 9:1631-1637, 1995
16. Berman E, Adams M, Duigou-Osterndorf R, et al: Effect of tamoxifen on cell lines displaying the multidrug resistant phenotype. Blood 77:818-825, 1991
17. List A, Spier C, Greer J, et al: Phase I/II trial of cyclosporin as a chemotherapy-resistance modifier in acute leukemia. J Clin Oncol 11:1652-1660, 1993
18. Erlichman C, Moore M, Thiessen JJ, et al: Phase I pharmacokinetic study of cyclosporin A combined with doxorubicin. Cancer Res 53:4837-4842, 1993
19. Lum BL, Kaubisch S, Yahanda AM, et al: Alteration of etoposide pharmacokinetics and pharmacodynamics by cyclosporine in a phase I trial to modulate multidrug resistance. J Clin Oncol 10:1635-1642, 1992
20. Weber D, Dimopoulous M, Sinicrope F, et al: VAD-cyclosporin therapy for VAD resistant myeloma. Blood 82:581a, 1993 (suppl 1, abstr)
21. Sonneveld P, Durie BGM, Lokhorst HM, et al: Modulation of multidrug-resistant multiple myeloma by cyclosporin. Lancet 340:255-259, 1992
22. O'Brien S, Kantarjian H, Estey E, et al: Mitoxantrone and high dose etoposide for patients with relapsed or refractory acute leukemia. Cancer 68:691-694, 1991
23. Boesh D, Gaveriaux C, Jachez B, et al: In vivo circumvention of P-glycoprotein-mediated multidrug resistance of tumor cells with SDZ PSC 833. Cancer Res 51:4226-4233, 1991
24. Boesch D, Muller K, Pourtier-Manzanedo A, et al: Restoration of daunomycin retention in multidrug-resistant P388 cells by submicromolar concentrations of SDZ PSC 833, a nonimmunosuppressive cyclosporin derivative. Exp Cell Res 196:26-32, 1991
25. Twentyman P, Bleehen N: Resistance modification by PSC-833, a novel nonimmunosuppressive cyclosporin A. Eur J Cancer 27:1639-1642, 1991
26. Pearce T, Israel R: PSC-833 Investigator's Brochure. East Hannover, NJ, Sandoz Pharmaceutical Corp, 1993
27. Estey E, Kornblau S, Pierce S, et al: A stratification system for evaluating and selecting therapies in patients with relapsed or primary refractory acute myelogenous leukemia. Blood 88:756, 1996 (letter)
28. Yong I: Proof without prejudice use of the Kolmogorov-Smirnov test for the analysis of histograms from flow systems and other sources. J Histochem Cytochem 26:935-941, 1977
29. Hu Y, Chang S, Law C, et al: Pharmacokinetic and pharmacodynamic studies with mitoxantrone in the treatment of patients with nasopharyngeal carcinoma. Cancer 69:847-853, 1992
30. Madden T, Cacek T: Altered etoposide protein binding in patients with multiple myeloma. Clin Pharmacol Ther 53:175, 1993
31. Madden T, Mirro J, Belt J, et al: Etoposide (VP-16) disposition in children with acute myeloblastic leukemia, in Acute Leukemias III: Prognostic Factors and Treatment Strategies. New York, NY, Springer-Verlag, 1992
32. Rodman J, Murray D, Madden T: Altered etoposide pharmacokinetics and time to engraftment in pediatric patients undergoing autologous bone marrow transplantation. J Clin Oncol 12:2390-2397, 1994
33. Boote D, Dennis P, Twentyman R: Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol 14:610-618, 1996
34. Keller R, Altermatt H, Donatsh P, et al: Pharmacologic interactions between the resistance-modifying cyclosporine SDZ PSC 833 and etoposide (VP 16-213) enhance in vivo cytostatic activity and toxicity. Int J Cancer 51:433-438, 1992
35. Keller R, Altermatt H, Nooter K, et al: A non-immunosuppressive cyclosporine: Its potency in overcoming P-glycoprotein-mediated multidrug resistance of murine leukemia. Int J Cancer 50:593-597, 1992
36. Consoli U, Van NT, Mahadevia R, et al: Cellular pharmacology of mitoxantrone in human leukemia cell lines is affected by p-glycoprotein expression. Blood 82:257a, 1993 (abstr)
37. Andreeff M: Characterization and therapy monitoring of leukemia, in Flow Cytometry in Hematology. New York, NY, Harcourt Brace Jovanovich, 1992, pp 232-260