Palifermin for Stem Cell Transplant Outcomes

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySteven Z Pavletic, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Background: - In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is less likely when the recipient and donor have similar human leukocyte antigens (HLA). Researchers want to see if the drug palifermin improves the results of allogeneic SCT from HLA-matched unrelated donors. Objective: - To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and improve immune function after transplant. Eligibility: - Adults 18 years of age or older with blood or bone marrow cancer with no HLA-matched sibling, but with a possible HLA-matched donor. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have scans and heart and lung exams. * Before transplant, participants will: * Have many tests and exams. These include blood tests throughout the study and bone marrow biopsy. * Get a central line catheter if they do not have one. * Have 1-3 rounds of chemotherapy. * Take more tests to make sure they can have the transplant, including medical history, physical exam, and CT scan. * Get palifermin by IV and more chemotherapy. They will get other drugs, some they will take for 6 months. * Participants will get the SCT. * After transplant, participants will: * Be hospitalized at least 3-4 weeks. * Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and biopsies. * Stay near D.C. for 3 months. * Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.

Research Team

Steven Z Pavletic, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults over 18 with blood or bone marrow cancer, no HLA-matched sibling donor but a potential unrelated match, must understand and consent to the study. They should have good physical function, agree to use contraception if applicable, and live in the US. Excluded are HIV patients, pregnant women, those with certain psychiatric conditions or active infections not responding to treatment.

Inclusion Criteria

I don't have a family donor but may have a match in a donor registry.

I have been diagnosed with a blood cancer that meets certain criteria.

My acute lymphoblastic leukemia is in its first complete remission.

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Exclusion Criteria

You live outside of the United States.

History of psychiatric disorder or any other condition which may compromise compliance with transplant protocol or expose patient to unnecessary risk as determined by principal investigator or lead associate investigator

I have an infection that isn't getting better with treatment.

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Treatment Details

Interventions

Palifermin (Growth Factor)

Trial OverviewThe trial is testing high doses of palifermin given before chemotherapy for safety and effectiveness in preventing chronic GVHD and improving immune function after an allogeneic stem cell transplant from HLA-matched unrelated donors.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: 2/ Phase II armExperimental Treatment7 Interventions

Induction chemotherapy, then palifermin at the MTDdetermined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression

Group II: 1/Phase 1: Dose escalation armExperimental Treatment7 Interventions

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression