Status:
COMPLETED
Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Sarcoma
Oral Mucositis
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Palifermin is similar to a protein keratinocyte growth factor (KGF) that is naturally made in your body in small amounts. The function of palifermin is to stimulate the growth of specific cells that f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00267046
Start Date
December 1 2005
End Date
July 1 2009
Last Update
May 16 2012
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030