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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 3

Conditions: Stomatitis; Gastrointestinal Diseases; Candidiasis, Oral

Treatments: Drug: Nystatin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00001812

99-C-0097

990097

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.