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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001812 |
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 | Intervention | Phase |
|---|---|---|
|
Candidiasis, Oral Gastrointestinal Diseases Stomatitis |
Drug: Nystatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 84 |
| Study Start Date: | April 1999 |
| Estimated Study Completion Date: | August 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 |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001812 History of Changes |
| Other Study ID Numbers: | 990097, 99-C-0097 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Mucositis Oral Candidiasis Prophylaxis Stomatitis Swish and Swallow |
|
Candidiasis Candidiasis, Oral Gastrointestinal Diseases Stomatitis Mycoses Mouth Diseases Stomatognathic Diseases Digestive System Diseases Interleukin-2 Nystatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Antifungal Agents Anti-Infective Agents Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
