Not Signed In -
Nystatin Troche |
Mycostatin Pastilles |
Clinical Trial: A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2
This study has been completed.
Purpose
In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.
| Condition | Phase |
|---|---|
| Candidiasis, Oral Gastrointestinal Diseases Stomatitis | Phase III |
MedlinePlus related topics: Candidiasis; Digestive Diseases; Mouth Disorders
Study Type: Interventional
Study Design: Treatment, Efficacy
Expected Total Enrollment: 84
Study start: April 26, 1999; Study completion: August 24, 2000
In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.
Eligibility
Genders Eligible for Study: Both
Criteria
All inclusion criteria as stated in the parent immunotherapy protocol apply:
No patients with evidence of oral irritation prior to starting therapy;
No patients with any known sensitivity to nystatin;
No patients receiving systemic antifungals;
No patients with active oral infections.
In additional, all exclusion criteria as stated in the parent immunotherapy protocol.
Location Information
Maryland
National Cancer Institute (NCI), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
More Information
Publications
Marmary Y, Shiloni E, Katz J. Oral changes in interleukin-2 treated patients: a preliminary report. J Oral Pathol Med. 1992 May;21(5):230-1.
Rodriguez-Archilla A, Urquia M, Cutando A, Asencio R. Denture stomatitis: quantification of interleukin-2 production by mononuclear blood cells cultured with Candida albicans. J Prosthet Dent. 1996 Apr;75(4):426-31.
Rosenberg SA, Lotze MT, Muul LM, Leitman S, Chang AE, Ettinghausen SE, Matory YL, Skibber JM, Shiloni E, Vetto JT, 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 Dec 5;313(23):1485-92.
Record last reviewed: April 1, 2000
Last Updated: December 11, 2002
Record first received: November 3, 1999
ClinicalTrials.gov Identifier: NCT00001812
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Mycostatin Pastilles (Drug Digest)
- Nystatin Troche (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
