A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Nystatin on the Development of Oral Irritation in Patients Receiving High-Dose Intravenous Interleukin-2

Journal of Immunotherapy

Volumn 24, Issue 2, 2001, Pages 188-192

  Ohnmacht, Galen A ^a   Phan, Giao Q ^a   Mavroukakis, Sharon A ^a   Steinberg, Seth M ^a   Shea, Yvonne R ^a   Witebsky, Frank G ^a   McIntyre, Lori S ^b   Goodwin, Rose S ^b   Muehlbauer, Paula M ^b   Morton, Kathleen E ^b   Rogers Freezer, Linda J ^b   Seipp, Claudia A ^b   Rosenberg, Steven A ^b   Marincola, Francesco M ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Interleukin 2; Nystatin; Oral irritation; Oral pain; Placebo; Prospective randomized trial; Thrush

Indexed keywords

NYSTATIN; PLACEBO; RECOMBINANT INTERLEUKIN 2;

ARTICLE; CANCER IMMUNOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDICATION; DRUG MEGADOSE; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; MELANOMA; MOUTH DISEASE; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THRUSH;

ADULT; AGED; ANTIBIOTICS, ANTIFUNGAL; CANDIDIASIS, ORAL; CARCINOMA, RENAL CELL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTERLEUKIN-2; KIDNEY NEOPLASMS; MALE; MELANOMA; MIDDLE AGED; MOUTH DISEASES; NYSTATIN; PLACEBOS; PROSPECTIVE STUDIES;

EID: 0035124028     PISSN: 15249557     EISSN: 15374513     Source Type: Journal    
DOI: 10.1097/00002371-200103000-00014     Document Type: Article

References (10)

1. 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.
2. Royal RE, Steinberg SM, Krouse SE, et al. Correlates of response to IL-2 therapy in patients treated for metastatic renal cancer and melanoma. Cancer J Sci Am 1996; 2:91-8.
3. Rosenberg SA, Lotze MT, Muul LM, et al. Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med 1985; 313:1485-92.
4. Margolin KA, Rayner AA, Hawkins MJ, et al. Interleukin-2 and lymphokine activated killer cell therapy of solid tumors: Analysis of toxicity and management guidelines. J Clin Oncol 1989; 7:486-98.
5. Gaspari AA, Lotze MT, Rosenberg SA, et al. Dermatologic changes associated with interleukin-2 administration. JAMA 1987; 258:1624-9.
6. Ridolfi R, Maltoni R, Riccobon A, et al. Evaluation of toxicity of 22 patients treated with subcutaneous IL-2, alpha interferon with and without chemotherapy. J Chemother 1992; 4:394-8.
7. Pons V, Greenspan D, Lozada-Nur F, et al. Oropharyngeal candidiasis in patients with AIDS: Randomized comparison of fluconazole versus nystatin oral suspensions. Clin Infect Dis 1997; 24:1204-7.
8. MacPhail LA, Hilton JF, Dodd CL, et al. Prophylaxis with nystatin pastilles for HIV-associated oral candidiasis. J Acquir Immune Defic Syndr Hum Retrovirol 1996; 12:470-6.
9. Myles EG, duBouchet L, Aulicino TM, et al. A comparative trial of clotrimazole troches and oral nystatin suspension in recipients of renal transplants. JAMA 1987; 258:2553-5.
10. Scott J, Huskisson EC. Graphic representation of pain. Pain 1976; 2:175-84.