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Phase I Study of Transforming Growth Factor-beta-2 Administered as a Mouthwash to Alleviate Stomatitis in Patients Receiving Fluorouracil-Based Chemotherapy for Metastatic Cancer (Summary Last Modified 07/97)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Supportive care

Completed

18 and over

NCI

GUMC-T94-0029
NCI-94-C-0123B, NCI-T94-0029N, T94-0029

Objectives

I.  Evaluate the tolerance in patients with fluorouracil-induced stomatitis to 
transforming growth factor-beta-2 (TGF-beta-2) administered orally at 25, 75, 
and 250 mcg doses.

II.  Describe any toxicities of TGF-beta-2 administered orally on this 
schedule.

III.  Evaluate the efficacy of TGF-beta-2 in ameliorating fluorouracil-induced 
stomatitis in these patients.

IV.  Assess patient compliance regarding mouthwash use and  completion of a 
self-assessment questionnaire.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:


--Population Characteristics--

Patients at least 18 years of age receiving fluorouracil-based
chemotherapy and who experienced grade 2 stomatitis on prior
course
  No changes in chemotherapy dose anticipated for the next
  course (i.e., disease is stable or responding)

No complicating oral disease

No concurrent colony stimulating factors (e.g., GM-CSF) or
interferon gamma

No pregnant women
Effective contraception required of fertile women

Expected Enrollment

18 patients who complete 2 courses (1 without and 1 with TGF-beta-2) will be 
entered within 12 months.

Outline

Biological Response Modifier Therapy.  Recombinant Transforming Growth 
Factor-beta-2 (Celtrix), TGF-beta-2, diluted in Clear Choice mouthwash.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

John Marshall, MD, Protocol chair
Ph: 202-444-7064

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.