Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Sarcoma, Oral Mucositis

In brief

Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. 2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. 3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy. Exploratory: 1. To evaluate the biologic effect of palifermin on oral mucosa. 2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma. 3. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.

Key facts

Study ID

NCT00267046

Run by

M.D. Anderson Cancer Center

People needed

49

Starts

2005-12-01

Expected to finish

2009-07-01

Last updated by the study team

2012-05-16

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (90 mg/m2) with ifosfamide (AI) or cisplatinum (AP) is indicated.
• Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months, negative blood pregnancy test, or no previous surgical sterilization) must use adequate birth control.
• Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm\^3, >/= Hgb 10gm/dL, platelet count >/= 150,000/mm\^3), renal (serum creatinine </= 1.5mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and SGPT < 3 * normal) functions.
• Karnofsky Performance Status >/= 80.
• Signed informed consent form.

You may not qualify if…

• Pregnant or lactating women.
• Patients with comorbid condition which renders patients at high risk of treatment complication.
• Patients with metastatic disease to CNS.
• Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia, acute myocardial infarction within 3 months or has uncontrolled hypertension.
• Patient has an active seizure disorder. Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years.
• Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
• Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2).
• Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is to obtain post-treatment data on the subject (eg, long-term follow-up or survival data).
• Known sensitivity to any of the products to be administered during this study, including Escherichia coli-derived products.
• Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
• Patients with a history of pancreatitis.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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