Status:
WITHDRAWN
Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Mucositis
Malignant Neoplasm
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients un...
Detailed Description
PRIMARY OBJECTIVES: I. To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic ste...
Eligibility Criteria
Inclusion
- Criteria:
- Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
- Any type of myeloablative HSCT conditioning regimen allowed
- Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells:
- HLA-matched sibling or parent
- Partially matched family donor (mismatched for a single HLA locus \[class I\])
- Fully matched unrelated marrow or peripheral blood stem cell donor
- HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II)
- Fertile patients must use effective contraception
- No HIV positivity
- No known sensitivity to any E. coli-derived products
- Known grade 1 to 2 allergic reactions to asparaginase allowed
- No prior grade 3-4 allergies to asparaginase or pegaspargase
- More than 30 days since prior and no concurrent treatment with any of the following therapies:
- Oral cryotherapy
- Glutamine as an oral supplement
- Traumeel
- Gelclair
- Oral vancomycin paste
- Low-level laser therapy
- An investigational product or device in another clinical trial
- No prior palifermin or other keratinocyte growth factors
- No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis (intrathecal methotrexate or cytarabine for CNS involvement allowed)
- Not pregnant or nursing
Exclusion
Key Trial Info
Start Date :
March 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00728585
Start Date
March 13 2008
Last Update
August 7 2018
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