Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:8/3/2018
Start Date:November 2011
End Date:November 2018

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A Feasibility Trial of Everolimus (RAD001),an mTOR Inhibitor, Given in Combination With Multiagent Re-Induction Chemotherapy in Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia (ALL)

Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent
tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus
is approved for use in the United States for certain types of cancer, such as kidney cancer.
It has been extensively studied in people with various types of cancer as a single agent (a
drug that is used alone to treat the cancer) or in combination with a number of other drugs.
Studies in adults with cancer have also evaluated Everolimus in combination with other
anti-tumor drugs. Information from lab studies and some other clinical trials suggests that
Everolimus may kill leukemia cells on its own, and also make it more likely that steroids
(such as prednisone) are able to kill leukemia cells.

In this research study, we are looking to learn more about how Everolimus works in
combination with other drugs which are commonly used to treat relapsed acute lymphoblastic
leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the
study is to evaluate the side effects of this treatment combination in order to determine a
safe dose of Everolimus which can be given with these other 4 drugs.

Study Treatment: The study treatment lasts 32 days during which time you will be taking the
study drug Everolimus daily for 32 days in addition to standard chemotherapy drugs. Below
lists the study drug as well as the other drugs you will be receiving to treat your leukemia
during this research study.

Chemotherapy drugs:

1. Everolimus (RAD001): By mouth Daily 1-32

2. Prednisone: By mouth or in the vein Three times daily on days 4-32

3. Vincristine: In the vein Daily on days 4, 11, 18, and 25

4. Doxorubicin: In the vein Once per day on days 4 and 5. A drug called dexrazoxane will be
given with each dose of Doxorubicin to protect the heart from any damage that might be
caused by Doxorubicin.

5. PEG-asparaginase: In the vein Once per day on days 5 and 18

If you have or have had an allergy to PEG-asparaginase, we will give another form of
asparaginase (Erwinia asparaginase). Four doses of Erwinia asparaginase will be given in the
muscle twice a week beginning on Day 5 and then another 4 doses will be given in the muscle
twice a week beginning on Day 15 in place of the scheduled doses of PEG-asparaginase.

In addition to the medications listed above, you will also be receiving intrathecal (IT)
chemotherapy that is given directly into your spinal fluid to treat the leukemia that may
have spread to your brain and spinal fluid. The medicines we will be giving in your spinal
fluid are listed below. The number of times we give chemotherapy into the spinal fluid will
depend on whether or not we see leukemia cells in your spinal fluid on the sample we take on
the first day of the study.

1. Cytarabine on Day 1 (also Day 4 if we see leukemia cells in your spinal fluid on the
screening spinal tap)

2. Triple intrathecal therapy (cytarabine, methotrexate and hydrocortisone)on Days 18 and
32 (if we do not see leukemia cells in your spinal fluid on the screening spinal tap),
or on Days 11, 18, 25 and 32 (if we see leukemia cells in your spinal fluid on the
screening spinal tap)

A drug called leucovorin will be given by mouth or by vein after each dose of triple
intrathecal therapy. Leucovorin is given to prevent mouth sores which might occur after you
get methotrexate in the spinal fluid. Leucovorin will be given three times a day for 24 hours
beginning one day after you receive a dose of triple intrathecal therapy.

Portions of this treatment are "routine" or "standard" ways of treating recurrent ALL.
Receiving vincristine, prednisone, PEG asparaginase and doxorubicin along with chemotherapy
in the spinal fluid is a standard treatment for relapsed leukemia. The research part of the
treatment involves giving Everolimus at the same time as these drugs.

Clinical and Lab Exams: During the study, you will have a physical examinations and you will
be asked questions about your general health and specific questions about any problems that
you might be having and any medications you may be taking. You will also have blood work to
check for any side effects to your organs from the study drug and other chemotherapy drugs.
Bone marrow studies will be done at the end of the 32-day treatment period to assess how you
responded to treatment. If you are in remission, a special minimal residual disease (MRD)
test will also be performed from the marrow sample as part of the study.

Inclusion Criteria:

- ALL in first bone marrow relapse occuring > 18 months from initial diagnosis

- Normal organ function

- Maximum prior cumulative doxorubicin dose of
Exclusion Criteria:

- Prior therapy for ALL except for intrathecal (IT) chemotherapy

- Pregnant or lactating

- Individuals whose relapsed ALL harbors a t(9;22)/BCR-ABL fusion

- Individuals whose lymphoblasts have surface immunoglobulin by flow cytometry and/or
t(8;14), t(2;8), or t(8;22)

- Down syndrome

- Prior stem cell transplant

- History of asparaginase-associated pancreatitis

- Active lung disease

- Impairment of gastrointestinal function or gastrointestinal disease

- Severe and/or uncontrolled intercurrent illness

- Documented history of previous or current Hepatitis B or C infection

- History of a different malignancy (other than ALL) unless disease-free for at 5 years
and deemed by the investigators to be at low risk for recurrence of that malignancy

- HIV positive on combination antiretroviral therapy
We found this trial at
8
sites
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Todd Cooper, DO
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Melinda Pauly, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Lia Gore, MD
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Lewis Silverman, MD
Phone: 617-632-6191
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Lewis Silverman, MD
Phone: 617-632-6191
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Noboku Hijiya, MD
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Maria Luisa Sulis, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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1635 Divisadero Street
San Francisco, California 94143
Principal Investigator: Mignon Loh, MD
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San Francisco, CA
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