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| Sponsored by: |
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: | Treatment, Efficacy Study |
| 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
| Study ID Numbers: | 990097, 99-C-0097 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001812 |
| Health Authority: | United States: Federal Government |
|
Mucositis Oral Candidiasis Prophylaxis Stomatitis Swish and Swallow |
|
Mouth Diseases Candidiasis, Oral Candidiasis Mucositis Stomatitis Gastrointestinal Diseases Clotrimazole |
Miconazole Tioconazole Nystatin Mycoses Digestive System Diseases Interleukin-2 Stomatognathic Diseases |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Membrane Transport Modulators Anti-Bacterial Agents Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Antifungal Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Ionophores |
