Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma Myeloma	Drug: Palifermin	Phase I

Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. Currently, no standard therapy is available to prevent or treat mucositis.

Ages Eligible for Study:  18 Years   -   76 Years,  Genders Eligible for Study:  Both

Criteria

• Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma.
• Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.

Amgen Call Center      866-572-6436    mit@amgen.com

North Carolina
      Research Site, Winston Salem,  North Carolina,  United States; Recruiting

Study ID Numbers:  20010182
Record last reviewed:  June 2004
Record first received:  October 6, 2003
ClinicalTrials.gov Identifier:  NCT00070616
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10