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...
Date First Received: November 3, 1999
Last Updated: March 3, 2008
Verified by: National Institutes of Health Clinical Center (CC), April 2000
Clinical Trial Phase: Phase 3 | Start Date: April 1999
Overall Status: Completed
Estimated Enrollment: 84
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Efficacy Study
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- Drug: Nystatin
Criteria for Participation in this Clinical Trial
- All patients enrolled on high dose intravenous interleukin-2 studies in the Surgery Branch of the National Cancer Institute are eligible, except for patients who are receiving adoptively transferred cells (cloned peripheral blood cells).
- 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.
All inclusion criteria as stated in the parent immunotherapy protocol apply:
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Cancer Institute (NCI)
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001812
Study ID Number: 990097
ClinicalTrials.gov Identifier: NCT00001812
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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