Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant
Gastrointestinal Mucositis, Malignant Neoplasm
About this trial
This is an interventional supportive care trial for Gastrointestinal Mucositis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (palifermin)
Arm II (placebo)
Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic hematopoietic stem cell transplantation.
Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic hematopoietic stem cell transplantation.