Phase I Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study uses a drug called dasatinib to produce an anti-cancer effect called large granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as natural killer cells that remove cancer cells. Researchers think that dasatinib may cause large granular lymphocyte expansion to happen in patients who have received a blood stem cell transplant (SCT) between 3 to 15 months after the blood SCT. In this research study, researchers want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at the best dose of dasatinib.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Recipients of first ASCT for the treatment of hematologic malignancies (multiple myeloma, Hodgkin's and non Hodgkin's lymphoma)

• Patients must be between 100 to 180 days after ASCT

• Dasatinib use prior to ASCT is allowed

• Performance status \>= 60%

• Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is \< 25% of T cell population

• Total bilirubin \< 2.0 times the institutional upper limit of normal (ULN)

• Hepatic enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) =\< 2.5 times the institutional ULN

• Serum creatinine \< 1.5 times the institutional ULN

• Hemoglobin \>= 8 g/dL

• Absolute neutrophil counts \>= 1,500 cells per uL

• Platelets \>= 100,000 per uL

• Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines

• Patient should be able to take oral medication (dasatinib must be swallowed whole)

Locations
United States
Michigan
Barbara Ann Karmanos Cancer Institute
Detroit
Time Frame
Start Date: 2015-02-12
Completion Date: 2018-10-09
Participants
Target number of participants: 8
Treatments
Experimental: Dasatinib
This is a phase 1 dose escalation study, using a standard 3+3 design. Dasatinib is administered orally once daily in the outpatient setting. The starting dose of dasatinib is 20 mg daily. The increment of dose escalation is 20 mg per dose level. Thus, there will be 5 dose levels (20 mg, 40 mg, 60 mg, 80 mg and 100 mg, respectively) with 3 patients in each cohort. Patients will continue on dasatinib for 6 months
Sponsors
Leads: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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