A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL). Panobinostat is a new drug that is considered investigational because it has not been approved in the United States by the Food and Drug Administration (FDA), or in any other country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene expression found in cells causing them to stop growing or die. Panobinostat has been used in several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not been given to children.
This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL.
Lymphoblastic Leukemia, Acute, Childhood
Myelogenous Leukemia, Acute, Childhood
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Finding Study Of Panobinostat In Children With Refractory Hematologic Malignancies|
- To find the highest dose of oral panobinostat that can be given to patients with relapsed AML, HD or NHL without causing severe side effects. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To learn what kind of side effects panobinostat can cause when taken by children with relapsed ALL, AML, HD or NHL. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To determine whether panobinostat is a beneficial treatment for ALL, AML, HD or NHL. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- To test the amount of panobinostat in the patient's blood and spinal fluid after taking panobinostat. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To test samples of cancer cells to see if they have chemicals that affect the way panobinostat works. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Leukemia Patients
Patients with ALL and AML will be treated in one arm of the study.
Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week given on a Monday, Wednesday, Friday schedule, every week. One course is 28 days (4 weeks). Patients will get 2 courses and may receive up to 8 courses total.
Other Name: LBH589Drug: Cytarabine
All patients will receive 70 mg of intrathecal cytarabine on day "0" of course 1. The day "0" dose must be given at least 24 hours prior to initiation of panobinostat. Omit the day "0" dose of intrathecal cytarabine if the patient received intrathecal therapy within 72 hours of treatment.
All patients will receive 70 mg of intrathecal cytarabine on day "29" of course 1-8 in conjunction with their disease evaluation.
Experimental: Lymphoma Patients
Patients with NHL or HD will be treated in one arm of the study.
Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week on a Monday, Wednesday, Friday schedule, every other week. Once course is 28 days (4 weeks). Patients will get 2 course and may receive up to 8 courses of therapy.
Other Name: LBH589
|Contact: Jeannette M van der Giessenfirstname.lastname@example.org|
|Contact: Elena Eckrothemail@example.com|
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