Protocol

PANSTAT: A Phase I Dose Finding Study Of Panobinostat In Children With Refractory Hematologic Malignancies

Diseases

Leukemias / Lymphomas : Relapsed acute lymphoblastic leukemia [ALL], acute myelogenous leukemia [AML], Hodgkin disease [HD] and non-Hodgkin’s lymphomas [NHL]

Description

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 this Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed acute lymphoblastic leukemia [ALL], acute myelogenous leukemia [AML], Hodgkin disease [HD] and non-Hodgkin’s lymphomas [NHL].

This is a study of an investigational drug called panobinostat. Panobinostat 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 changes genes found in cells causing them to stop growing and 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.

Objectives

• To find the highest dose of oral panobinostat that can be given to patients with relapsed ALL, AML, HD or NHL without causing severe side effects.
• To learn what kind of side effects panobinostat can cause when taken by children with relapsed ALL, AML, HD or NHL.
• To determine whether panobinostat is a beneficial treatment for your ALL, AML, HD or NHL.
• To test the amount of panobinostat in your blood and spinal fluid after you take the drug.
• To test samples of your cancer cells to see if they have chemicals that affect the way panobinostat works.

Eligibility

• Patient must be greater than 1 and less than or equal to 21 years of age at the time of enrollment;
• Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
• Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study
• Patients will be excluded if they are unable to swallow capsules whole.
• Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
• Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

Contact

Deepa Bhojwani, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.