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Last Updated: February 26, 2021

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CLINICAL TRIALS PROFILE FOR PALIFERMIN

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All Clinical Trials for palifermin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004061 Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer Completed National Cancer Institute (NCI) Phase 2 1999-05-01 RATIONALE: Biological therapy using growth factors may be effective in reducing side effects in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy, and peripheral stem cell transplantation. PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
NCT00004061 Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 1999-05-01 RATIONALE: Biological therapy using growth factors may be effective in reducing side effects in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy, and peripheral stem cell transplantation. PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
NCT00004132 Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer Completed National Cancer Institute (NCI) Phase 2 2000-01-01 RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.
NCT00004132 Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer Completed Jonsson Comprehensive Cancer Center Phase 2 2000-01-01 RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.
NCT00028236 Stem Cell Gene Therapy to Treat X-Linked Severe Combined Immunodeficiency (XSCID) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2001-12-01 This is a clinical trial of gene therapy for X-linked severe combined immunodeficiency (XSCID), a genetic disease caused by defects in a protein called the common gamma chain, which is normally on the surface of immune cells called lymphocytes. XSCID patients cannot make T lymphocytes, and their B lymphocytes fail to make essential antibodies for fighting infections. Without T and B lymphocytes patients develop fatal infections in infancy unless they are rescued by a bone marrow transplant from a healthy donor. However, even transplanted patients may achieve only partial immune recovery and still suffer from many infections, auto-immunity and/or and poor growth. A recent, successful trial in France used gene therapy instead of bone marrow transplantation for infants with XSCID. This experience indicates that gene therapy can provide clinical benefit to XSCID patients. We will enroll eight older XSCID patients (1.5-20 years-old), who have previously received at least one bone marrow transplant, but still have poor T and B lymphocyte function that compromises their quality of life. Before enrollment, these subjects will have had some of their own blood-forming stem cells harvested and frozen in a blood bank. These cells have a defective gene, but a correct copy of the gene will be inserted while the cells are grown in sterile conditions outside the patient's body. To do this, the cells will be unfrozen and exposed for four days in a row to growth factors and particles of a retrovirus we have constructed and tested called "GALV MFGS-gc." Retrovirus particles will attach to the patient cells and introduce a correct copy of the common gamma chain gene into cells capable of growing into all types of blood cells, including T and B lymphocytes. XSCID patients who are enrolled in the study will receive a single dose of their own cells that have been modified by the GALV MFGS-gc treatment and also will be given another drug called palifermin to help prevent side effects from the chemotherapy and possibly try to improve the development of the T cells. After this, the patients will be monitored to find out if the treatment is safe and to see if their immune function improves. Study endpoints are (1) efficient and safe clinical-scale transduction of HSC from post-BMT XSCID subjects; (2) administration of a nonmyeloablative conditioning regimen in older patients to improve engraftment; (3) administration of a transduced HSC to eight subjects; (4) administration of KGF to improve thymic function post transplant to improve T cell development; and (5) appropriate follow-up of the treated subjects to monitor vector sequence distribution, gc expression in hematopoietic lineages, and lymphoctye numbers and function as well as general health and immune status.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for palifermin

Condition Name

Condition Name for palifermin
Intervention Trials
Lymphoma 12
Leukemia 9
Multiple Myeloma 8
Mucositis 7
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Condition MeSH

Condition MeSH for palifermin
Intervention Trials
Mucositis 19
Stomatitis 16
Multiple Myeloma 12
Lymphoma 11
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Clinical Trial Locations for palifermin

Trials by Country

Trials by Country for palifermin
Location Trials
United States 65
United Kingdom 3
Germany 2
India 2
Canada 1
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Trials by US State

Trials by US State for palifermin
Location Trials
Texas 15
California 7
Maryland 6
New York 5
Tennessee 4
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Clinical Trial Progress for palifermin

Clinical Trial Phase

Clinical Trial Phase for palifermin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for palifermin
Clinical Trial Phase Trials
Completed 27
Recruiting 8
Active, not recruiting 5
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Clinical Trial Sponsors for palifermin

Sponsor Name

Sponsor Name for palifermin
Sponsor Trials
M.D. Anderson Cancer Center 14
Swedish Orphan Biovitrum 14
Amgen 10
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Sponsor Type

Sponsor Type for palifermin
Sponsor Trials
Other 43
Industry 29
NIH 12
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