Phase I study of treatment with oral 13-cis-retinoic acid, subcutaneous interferon alfa-2a, cisplatin, and 24-hour infusion 5-fluorouracil/leucovorin

Cancer Chemotherapy and Pharmacology

Volumn 39, Issue 3, 1996, Pages 227-232

  Fleming, Gini F ^a,b   O'Brien, Sheila M ^a   Hoffman, Philip C ^a,b   Vokes, Everett E ^a,b   Vogelzang, Nicholas J ^a,b   Schilsky, Richard L ^a,b   Waggoner, Steven E ^b   Ratain, Mark J ^a,b  

^a UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

Author keywords

13 cis Retinoic acid; Cisplatin; Interferon

Indexed keywords

ALPHA2A INTERFERON; CISPLATIN; FLUOROURACIL; FOLINIC ACID; ISOTRETINOIN; RECOMBINANT ALPHA2A INTERFERON; TRIACYLGLYCEROL; WARFARIN;

ADENOCARCINOMA; ADRENAL CANCER; ADULT; AGED; ANOREXIA; ARTICLE; ATAXIA; BLADDER CANCER; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CYTOPENIA; DIARRHEA; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LEUKOPENIA; MALE; MUCOSA INFLAMMATION; MYALGIA; NEPHROTOXICITY; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN CANCER; SKIN DISEASE; SQUAMOUS CELL; STOMACH CANCER; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTOPENIA; THROMBOSIS; UTERINE CERVIX CANCER;

EID: 0031060337     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800050565     Document Type: Article

References (52)

1. Aebi S, Kroning R, Jones JA, Naredi P, Los G, Howell SB, Christen RD (1995) All-trans retinoic acid (ATRA) enhances the activity of cisplatin (DDP) in head and neck cancer and ovarian cancer cell lines. Proc Am Assoc Cancer Res 36:287
2. Ardalan B, Singh G, Silberman H (1988) A randomized phase I and II study of short-term infusion of high-dose fluorouracil with or without N-(phosphonacetyl)-L-aspartic acid in patients with advanced pancreatic and colorectal cancers. J Clin Oncol 6:1053-1058
3. Ardalan B, Chua L, Tian E, Reddy R, Sridhar K, Benedetto P, Richman S, Legaspi A, Waldman S, Morrell L, Feun L, Savaraj N, Livingstone A (1991) A phase II study of weekly 24-hour infusion with high-dose fluorouracil with leucovorin in colorectal carcinoma. J Clin Oncol 9:625-630
4. Arnold A, Ayoub J, Douglas L, Hoogendoorn P, Skingley L, Gelmon K, Hirsh V, Eisenhauer E (1994) Phase II trial of 13-cis-retinoic acid plus interferon a in non-small-cell lung cancer. J Natl Cancer Inst 86:306-309
5. Arquette MA, Mortimer JE, Loehrer PJ, Mandanas RA (1994) A phase II Hoosier Oncology Group trial of interferon alpha-2b (IFN) added to cisplatin (CDDP) and 5-fluorouracil (FU) in recurrent or metastatic head and neck cancer. Proc Am Soc Clin Oncol 13:280
6. Bosscher JR, Taylor C, Taylor D, Doering DL, Lojun SL (1995) Effect of retinoic acid on the efficacy of cisplatin and taxol on ovarian cancer cell lines. Gynecol Oncol 56:121
7. Caliaro MJ, Lochon I, Nomhe A, Lafon C, Vaette A, Canal P, Bugat R, Jozan S (1995) Enhancement of cisplatin (CDDP) cytotoxicity by all trans retinoic acid (ATRA) on human ovarian cancer cell lines. Proc Am Assoc Cancer Res 36:293
8. Carmichael J, Ferguson RJ, Wolf CR, Balkwill FR, Smyth JF (1986) Augmentation of cytotoxicity of chemotherapy by human α-interferon in human non-small cell lung cancer xenografts. Cancer Res 46:4916-4920
9. Dhingra K, Papadopoulos N, Lippman S, Lotan R, Legha SS (1993) Phase II study of alpha interferon and 13-cis-retinoic acid in metastatic melanoma. Invest New Drugs 11:39-43
10. Dmitrovsky E, Bosl GJ (1992) Active cancer therapy combining 13-cis-retinoic acid with interferon-α J Natl Cancer Inst 84:218-219
11. Feirbeck G, Schreiner T, Rassner G (1995) Combination of highly purified human leukocyte interferon a and 13-cis-retinoic acid for the treatment of metastatic melanoma. Cancer Immunol Immunother 40:157-164
12. Formelli F, Cleris L (1995) Synthetic retinoid fenretinide is effective against a human ovarian carcinoma xenograft and potentiates cisplatin activity. Cancer Res 53:5374-5376
13. Frey JR, Peck R, Bollag W (1991) Antiproliferative activity of retinoids, interferon alpha, and their combination in five human transformed cell lines. Cancer Lett 57:223-227
14. Gonzales-de Leon C, Lippman SM, Kudelka AP, Edwards CL, Kavanagh JJ (1995) Phase II study of cisplatin, 5-fluorouracil and interferon-α in recurrent carcinoma of the cervix. Invest New Drugs 13:73-76
15. Greenblatt MS, Mangalik A, Ferguson J, Elias L (1995) Phase I evaluation of therapy with four schedules of 5-fluorouracil by continuous infusion combined with recombinant interferon alpha. Clin Cancer Res 1:615-620
16. 2a in heavily pretreated squamous carcinoma of the cervix. Gynecol Oncol 56:382-386
17. Hemmi H, Breitman TR (1987) Combinations of recombinant human interferons and retinoic acid synergistically induce differentiation of the human promyelocytic leukemia cell line HL-60. Blood 69:501-507
18. Higuchi T, Hannigan GE, Malkin D, Yeger H, Williams BRG (1991) Enhancement by retinoic acid and dibutyryl cyclic adenosine 3′:5′ monophosphate of the differentiation and gene expression of human neuroblastoma cells induced by interferon. Cancer Res 51:3958-3964
19. Hussain M, Benedetti J, Smith R, Schuller D, Ensley J (1994) Alpha interferon (aIFN) + 5-fluorouracil (5-FU) + cisplatin (CDDP) in advanced squamous cell carcinoma of the head and neck (SCCHN): a Southwest Oncology Group (SWOG) phase II trial. Proc Am Soc Clin Oncol 13:279
20. Ikic D, Krusic J, Kirhmajer V, Knezevic M, Maricic Z, Rode B, Jusic D, Soos E (1981) Application of human leucocyte interferon in patients with carcinoma of the uterine cervix. Lancet 1:1027-1030
21. Ilson DH, Kelsen DP, Saltz L, Martin L (1995) A phase II trial of interferon-alpha 2a (IFN-α) and 13-cis-retinoic acid (CRA) in esophageal carcinoma: no activity in adenocarcinoma. Proc Am Soc Clin Oncol 14:200
22. Kalemkerian G, Slusher R, Ramalingam S, Mabry M (1995) Fenretinamide inhibits growth and potentiates etoposide cytotoxicity in small cell lung cancer. Proc Am Assoc Cancer Res 36:510
23. κB in mouse embryonal carcinoma cells. Proc Natl Acad Sci USA 90:3167-3171
24. Kalvakolanu D, Mannino S, Lindner DJ, Borden EC (1994) Synergistic modulation of IFN-stimulated gene expression by retinoic acid in embryonal carcinoma and breast tumor cells. Proc Am Assoc Cancer Res 35:310
25. Kalvakolanu DV, Kolla V, Lindner DJ, Weihua X, Freund R, Borden EC (1995) Retinoic acid enhances IFN-regulated genes via the modulation of STAT1 protein in a breast tumor cell line. J Interferon Cytokine Res [Suppl] 15:S217
26. Kelsen D, Johnson B, Buckley M, Keresztes R, Saltz L, Dougherty JB (1992) αInterferon (INF), 5-fluorouracil (FU), and cisplatin (CDDP): an active regimen in advanced adenocarcinoma (adenoca) and squamous cancer (SCC) of the esophagus. Proc Am Soc Clin Oncol 11:172
27. Koller E, Krieger O, Kasparu H, Lutz D (1991) Restoration of all-trans retinoic acid sensitivity by interferon in acute promyelocytic leukemia. Lancet 338:1154-1155
28. Lancillotti F, Giandomenico V, Affabris E, Fiorucci G, Romeo G, Rossi GB (1995) Interferon α-2b and retinoic acid combined treatment affects proliferation and gene expression of human cervical carcinoma cells. Cancer Res 55:3158-3164
29. Legha SS, Dimery IW (1985) High-dose cisplatin administration without hypertonic saline: observation of disabling neurotoxicity. J Clin Oncol 3:1373-1378
30. Lindner DJ, Kalvakolanu DV, Borden EC (1995) A combination of retinoic acid and IFN-β inhibits the in vitro and in vivo growth of a variety of tumors. J Interferon Cytokine Res 15 [Suppl] 15:S217
31. Lippman SM, Kessler JF, Meyskens FL Jr (1987) Retinoids as preventive and therapeutic anticancer agents. Cancer Treat Rep 71:391 405 (part I), 493 515 (part II)
32. Lippman SM, Kavanagh JJ, Paredes-Espinoza M, Delgadillo-Madrueno F, Paredes-Casillas P, Hong WK, Holdener E, Krakoff IH (1992) 13-cis-retinoic acid plus interferon α-2a: highly active systemic therapy for squamous cell carcinoma of the cervix. J Natl Cancer Inst 84:241-245
33. Lippman SM, Parkinson DR, Itri LM, Weber RS, Schantz SP, Ota DM, Schusterman MA, Krakoff IH, Gutterman JU, Hong WK (1992) 13-cis-retinoic acid and interferon α-2a: Effective combination therapy for advanced squamous cell carcinoma of the skin. J Natl Cancer Inst 84:235-241
34. Logothetis C, Dieriner P, Ellerhors J, Amato R, Sella A, Zukiwski A, Kilbourn R (1992) A 61% response rate with 5-fluorouracil, interferon-α2b and cisplatin in metastatic chemotherapy refractory transitional cell carcinoma. Proc Am Ass Cancer Res 33:221
35. Majewski S, Szmurlo A, Marczak M, Jablonska S, Bollag W (1994) Synergistic effect of retinoids and interferon α on tumor-induced angiogenesis: anti-angiogenic effect on HPV-harboring tumor-cell lines. Int J Cancer 57:81-85
36. Marth C, Daxenbichter G, Dapunt O (1986) Synergistic antiproliferative effect of human recombinant interferons and retinoic acid in cultured breast cancer cells. J Natl Cancer Inst 77:1197-1202
37. Marth C, Daxenbichler G, Widschwendter M (1995) Combination of retinoic acid and interferons: mechanism of synergistic interaction. J Interferon Cytokine Res [Suppl] 15:S216
38. Matikainen S, Ronni T, Hurme M, Levy DE, Julkunen I (1995) Retinoic acid activates IRF-1 gene expression in promyelocytic NB4 cells and enhances cellular interferon sensitivity. J Interferon Cytokine Res [Suppl] 15:S216
39. Mirro J, Kalwinsky J, Whisnant P, Weck P, Chesney C, Murphy S (1985) Coagulopathy induced by continuous infusion of high doses of human lymphoblastoid interferon. Cancer Treat Rep 69:315-317
40. Motzer RJ, Schwartz L, Murray Law T, Murphy BA, Hoffman AD, Albino AP, Vlamis V, Nanus DM (1995) Interferon alfa-2a and 13-cis-retinoic acid in renal cell carcinoma: antitumor activity in a phase II trial and interactions in vitro. J Clin Oncol 13:1950-1957
41. Omura GA (1994) Chemotherapy for cervix cancer. Semin Oncol 21:54-62
42. Recchia F, Sica G, DeFilippis S, Discepoli S, Rea S, Torchio P, Frati L (1995) Interferon-β, retinoids, and tamoxifen in the treatment of metastatic breast cancer: a phase H study. J Interferon Cytokine Res 15:605-610
43. Ronnblom LE, Alm GU, Oberg KE (1991) Autoimmunity after alpha-interferon therapy for malignant carcinoid tumors. Ann Intern Med 115:178-183
44. Sacchi S, Kantarjian H, O'Brien S, Cohen PR, Pierce S, Talpaz M (1995) Immune-mediated and unusual complications during inlerferon alfa therapy in chronic myelogenous leukemia. J Clin Oncol 13:2401-2407
45. Sacks PJ, Harris D, Chou T-C (1995) Modulation of growth and proliferation in squamous cell carcinoma by retinoic acid: a rationale for combination chemotherapy with chemotherapeutic agents. Int J Cancer 51:1-7
46. Shalinsky DR, Bischoff ED, Gregory ML, Lamph WW, Heyman RA, Hayes JS, Thomazy V, Davies PJA (1996) Enhanced antitumor efficacy of cisplatin in combination with ALRT 1057 (9-cis retinoic acid) in human oral squamous carcinoma xenografts in nude mice. Clin Cancer Res 2:511-520
47. Shirinian M, Choski AJ, Dimery I, Heyne K, Lippman S, Guillory C, Hong WK (1992) Phase I/II study of cisplatin (P) + 5-fluorouracil (F) + α-interferon (IFN) for recurrent squamous cell carcinoma of the head and neck (SCCHN). Proc Am Soc Clin Oncol 11:249
48. Toma S, Palumbo R, Vincenti M, Aitini E, Paganini G, Pronzato P, Grimaldi A, Rosso R (1994) Efficacy of recombinant alpha-interferon 2a and 13-cis-retinoic acid in the treatment of squamous cell carcinoma. Ann Oncol 5:463-465
49. Vokes EE (1994) The promise of biochemical modulation in combined modality therapy. Semin Oncol 21[suppl 14]: 29-33
50. Vokes EE, Ratain MJ, Mick R, McEvilly JM, Haraf D, Kozloff M, Hamasaki V, Weichselbaum RR, Panje WR, Wenig B, Berezin K (1993) Cisplatin, fluorouracil, and leucovorin augmented by interferon alfa-2b in head and neck cancer: a clinical and pharmacologic analysis. J Clin Oncol 11:360-368
51. Voravud N, Lippman SM, Weber RS, Rodriguez GI, Yee D, Dimery IW, Earley CL, Von Hoff DD, Hong WK (1993) Phase II trial of 13-cis-retinoic acid plus interferon-alpha in recurrent head and neck cancer. Invest New Drugs 11:57-60
52. Wadler S, Schwartz EL (1990) Antineoplastic activity of the combination of interferon and cytotoxic agents against experimental and human malignancies: a review. Cancer Res 50:3473-3486