Phase I trial of sequential low-dose 5-aza-2′-deoxycytidine plus high-dose intravenous bolus interleukin-2 in patients with melanoma or renal cell carcinoma

Clinical Cancer Research

Volumn 12, Issue 15, 2006, Pages 4619-4627

  Gollob, Jared A ^a,b   Sciambi, Catherine J ^a,b   Peterson, Bercedis L ^a   Richmond, Tina ^a   Thoreson, Monica ^a   Moran, Kelly ^a   Dressman, Holly K ^a   Jelinek, Jaroslav ^c   Issa, Jean Pierre J ^c  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DURHAM VA MEDICAL CENTER   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

5 AZA 2' DEOXYCYTIDINE; GRANULOCYTE COLONY STIMULATING FACTOR; INTERLEUKIN 2;

ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DNA METHYLATION; DNA MICROARRAY; DOSE RESPONSE; DRUG POTENTIATION; DRUG RESPONSE; FATIGUE; FEMALE; FEVER; FLUID RETENTION; GENE EXPRESSION; HEART ARRHYTHMIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERBILIRUBINEMIA; HYPOTENSION; IMMUNOTHERAPY; INFECTION; KIDNEY CARCINOMA; LEUKOPENIA; MALE; MELANOMA; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA; TOXICITY; WEIGHT GAIN;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AZACITIDINE; CARCINOMA, RENAL CELL; DNA METHYLATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; FEMALE; FETAL HEMOGLOBIN; FOLLOW-UP STUDIES; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN-2; KIDNEY NEOPLASMS; LEUKOCYTES, MONONUCLEAR; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; TREATMENT OUTCOME;

EID: 33748046812     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-06-0883     Document Type: Article

References (23)

1. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 1999;17:2105-16.
2. Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am 2000;6:355-7.
3. Mule JJ, Yang JC, Afreniere RL, Shu SY, Rosenberg SA. Identification of cellular mechanisms operational in vivo during the regression of established pulmonary metastases by the systemic administration of high-dose recombinant interleukin 2. J Immunol 1987;139:285-94.
4. Weber JS, Jay G, Tanaka K, Rosenberg SA. Immunotherapy of a murine tumor with interleukin 2. Increased sensitivity after MHC class I gene transfection. J Exp Med 1987;166:1716-33.
5. Hersey P, Zhang XD. How melanoma cells evade TRAIL-induced apoptosis. Nat Rev 2001;1:142-50.
6. Coral S, Sigalotti L, Altomonte M, et al. 5-aza-2′-deoxycytidine- induced expression of functional cancer testis antigens in human renal cell carcinoma: immunotherapeutic implications. Clin Cancer Res 2002;8:2690-5.
7. Weiser TS, Quo ZS, Ohnmacht GA, et al. Sequential 5-aza-2′- deoxycytidine-depsipeptide FR901228 treatment induces apoptosis preferentially in cancer cells and facilitates their recognition by cytolytic T lymphocytes specific for NY-ESO-1. J Immunother 2001;24:151-61.
8. Serrano A, Tanzarella S, Lionella I, et al. Re-expression of HLA class I antigens and restoration of antigen-specific CTL response in melanoma cells following 5-aza-2′-deoxycytidine treatment. int J Cancer 2001; 94:243-51.
9. Soengas MS, Capodieci P, Polsky D, et al. Inactivation of the apoptosis effector Apaf-1 in malignant melanoma. Nature 2001;409:207-11.
10. Fulda S, Kufer MU, Meyer E, et al. Sensitization for death receptor- or drug-induced apoptosis by re-expression of caspase-8 through demethylation or gene transfer. Oncogene 2002;20:5865-77.
11. Ueki T, Takeuchi T, Nishimatsu H, et al. Silencing of the caspase-1 gene occurs in murine and human renal cancer cells and causes solid tumor growth in vivo. Int J Cancer 2001;91:673-9.
12. Dreijerink K, Braga E, Kuzmin I, et al. The candidate tumor suppressor gene, RASSF1A, from human chromosome 3p21.3 is involved in kidney tumorigenesis. Proc Natl Acad Sci U S A 2001;98:7504-9.
13. Sarkar S, Roy BC, Hatano N, et al. A novel ankyrin repeat-containing gene (kank) located at 9p24 is a growth suppressor of renal cell carcinoma. J Biol Chem 2002;277:36585-91.
14. Koshy M, Dorn L, Bressler L, et al. 2-deoxy 5-azacytadine and fetal hemoglobin induction in sickle cell anemia. Blood 2000;96:2379-84.
15. DeSimone J, Koshy M, Dorn L, et al. Maintenance of elevated fetal hemoglobin levels by decitabine during dose interval treatment of sickle cell anemia. Blood 2002;99:3905-8.
16. Saunthararajah Y, Hillery CA, Lavelle D, et al. Effects of 5-aza-2-deoxycytidine on fetal hemoglobin levels, red cell adhesion, and hematopoietic differentiation in patients with sickle cell disease. Blood 2003;102:3865-70.
17. Gollob JA, Veenstra KG, Parker RA, et al. Phase I trial of concurrent twice-weekly recombinant human interleukin-12 plus low-dose IL-2 in patients with melanoma or renal cell carcinoma. J Clin Oncol 2003;21:2564-73.
18. Clark SJ, Harrison J, Paul CL, et al. High sensitivity mapping of methylated cytosines. Nucleic Acids Res 1994;22:2990-7.
19. Yang AS, Estecio MR, Doshi K, et al. A simple method for estimating global DNA methylation using bisulfite PCR of repetitive DNA elements. Nucleic Acids Res 2004;32:e38.
20. Gollob JA, Sciambi CJ, Huang Z, Dressman HK. Gene expression changes and signaling events associated with the direct antimelanoma effect of IFN-γ. Cancer Res 2005;65:8869-77.
21. Rosenberg SA, Yang JC, Topalian SL, et al. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA 1994;271:907-13.
22. Awogu AU. Leucocyte counts in children with sickle cell anaemia: usefulness of stable state values during infections. West Afr J Med 2000;19:55-8.
23. Abrams SI. Role of anti-CTLA-4 therapies in the treatment of cancer. Curr Opin Mol Ther 2004;6:71-7.