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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


Phase 3
N/A
N/A
Not Enrolling
Both
Candidiasis, Oral, Gastrointestinal Diseases, Stomatitis

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Trial Information

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


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.

Inclusion Criteria


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).

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

990097

NCT ID:

NCT00001812

Start Date:

April 1999

Completion Date:

August 2000

Related Keywords:

  • Candidiasis, Oral
  • Gastrointestinal Diseases
  • Stomatitis
  • Mucositis
  • Oral Candidiasis
  • Prophylaxis
  • Stomatitis
  • Swish and Swallow
  • Candidiasis
  • Candidiasis, Oral
  • Gastrointestinal Diseases
  • Digestive System Diseases
  • Stomatitis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892