Trial Information

ADVL0816: A Phase I Study of Obatoclax (Pan Anti-Apoptotic BCL-2 Family Small Molecule Inhibitor), in Combination with Vincristine/Doxorubicin/Dexrazoxane, in Children with Relapsed/Refractory Solid Tumors or Leukemia

What is the purpose of this study?

To find the highest safe dose of obatoclax that can be given with chemotherapy (vincristine, doxorubicin, and dexrazoxane) without causing severe side effects
To learn what kind of side effects obatoclax and obatoclax plus chemotherapy can cause
To learn more about the pharmacology (how your body handles the drug) of obatoclax
To learn more about the biology of obatoclax
To determine whether obatoclax is a beneficial treatment for your tumor

Who will be included in this study?
Patients between the ages of 6 months old and 21 years old who have a recurrent or progressive solid tumor or leukemia that likely cannot be cured by any known standard treatment may be eligible to participate in this study.

What is involved? Before patients can participate in this study, they will take part in a screening process that will include:

A medical history
Physical exam
Vital signs (blood pressure, pulse, temperature)
Blood tests
Urine tests
Pregnancy test (if you are a woman who could have children)
Electrocardiogram (EKG) and Echocardiogram (ECHO) or MUGA scan, which are tests that monitor the function of your heart
Lumbar puncture (spinal tap) to check your cerebrospinal fluid (CSF) which is the fluid that surrounds the spinal cord (for patients with leukemia)
Bone marrow aspirates (for patients with leukemia)
We will also do whatever X-rays, CT scans, or other tests that are needed to check your tumor

The following tests are all necessary to make sure that patients are not having unsafe side effects of Obatoclax:

Physical exam
Blood tests
Electrocardiogram (EKG) and Echocardiogram (ECHO) or MUGA scan, which are tests that monitor the function of your heart
We will also do whatever X-rays, CT scans, or other tests that are needed to check your tumor

What are the benefits?
There may be no direct benefit to participation in this research study. The potential benefit of the treatment with obatoclax is that it may cause your cancer to stop growing or to shrink for a period of time. It may lessen the symptoms, such as pain, that are caused by the cancer. Because there is not much information about the effect of obatoclax on cancers in humans, we do not know if you will benefit from taking part in this study. Information learned from this study may help future patients with cancer.

Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-2799
Email: cancer@cchmc.org

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Research Center Information: Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation

If you would like to learn more about participating in this study, please send an email message using the form below.

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