Protocol

SURVIN: A Phase I Study Evaluating the Safety, Tolerability and Biological Activity of EZN-3042, a Survivin mRNA Antagonist, Administered with Re-Induction Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) [IND 108753]

Diseases

Leukemias / Lymphomas : Acute lymphoblastic leukemia

Description

Acute lymphoblastic leukemia (ALL) in children presents a significant challenge, particularly when relapses occur very early (within 18 months from initial diagnosis), or in cases of second or greater recurrence. Patients who experience a relapse of ALL or who don’t achieve a remission have a poor outcome.

This study uses a new agent called EZN-3042 which targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow. Several survivin antagonists [a drug that counteracts, blocks, or abolishes the action of a gene or protein] have been developed for clinical use. The duration of the study will be for 2 years.

This study anticipates that the new investigational drug EZN-3042 will be safe and tolerable when given both alone and in combination with standard chemotherapy drug.

Objectives

The goal of this phase I study is to find out the dose of EZN-3042 that can be safely given without serious side effects both alone and in combination with standard chemotherapy drugs during re-induction.

Eligibility

• Patients must be greater than or equal to 1 years of age and less than or equal to 21 years of age.
• Patients must have a diagnosis of relapsed or refractory B-precursor acute lymphoblastic leukemia with ≥ 25% blasts in the bone marrow
• Patients may have Central Nervous System 1, 2 or 3 disease.
• Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
• Female patients with infants must agree not to breastfeed their infants while on this study.
• 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 with Down syndrome, psychiatric disorders, or if they are currently receiving any other investigational drugs are not eligible for the study

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.