NCT00001812

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 1999

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Candidiasis, OralGastrointestinal DiseasesStomatitis

Keywords

MucositisOral CandidiasisProphylaxisStomatitisSwish and Swallow

Interventions

NystatinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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. doi: 10.1111/j.1600-0714.1992.tb00107.x.

    PMID: 1403839BACKGROUND

  • 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. doi: 10.1016/s0022-3913(96)90036-0.

    PMID: 8642530BACKGROUND

  • 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. doi: 10.1056/NEJM198512053132327.

    PMID: 3903508BACKGROUND

MeSH Terms

Conditions

Candidiasis, OralGastrointestinal DiseasesStomatitisMucositis

Interventions

Nystatin

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesDigestive System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

April 1, 1999

Study Completion

August 1, 2000

Last Updated

March 4, 2008

Record last verified: 2000-04

Locations

US(1)