Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 undergoing stem cell transplant. Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Mitogens

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:

1. HLA-matched sibling or parent

2. Partially matched family donor (mismatched for a single HLA locus [class I])

3. Fully matched unrelated marrow or peripheral blood stem cell donor

4. 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

1. Known grade 1 to 2 allergic reactions to asparaginase allowed

2. 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:

1. Oral cryotherapy

2. Glutamine as an oral supplement

3. Traumeel

4. Gelclair

5. Oral vancomycin paste

6. Low-level laser therapy

7. 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