Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma



Status:Active, not recruiting
Conditions:Cancer, Other Indications, Brain Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:Any - 21
Updated:2/17/2019
Start Date:March 19, 2012

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A Phase II Randomized Trial of Lenalidomide (NSC # 703813) in Pediatric Patients With Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

This randomized phase II trial studies how well low-dose lenalidomide works compared with
high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or
optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment
(refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may
stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known
whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in
treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.

PRIMARY OBJECTIVES:

I. To determine the objective response rate in children with recurrent, refractory, or
progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with
Regimen A low-dose (20 mg/m^2/dose) or Regimen B high-dose (115 mg/m^2/dose) lenalidomide.

SECONDARY OBJECTIVES:

I. To estimate the event-free survival (EFS) (based on standard two-dimensional tumor
measurements, determined by each institution) of children with recurrent, refractory, or
progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with
lenalidomide.

II. To compare response categories and EFS across the 3 magnetic resonance (MR) sequences
(T2-weighted, fluid attenuated inversion recovery [FLAIR], T1-weighted post-contrast).

III. To correlate steady-state pharmacokinetics of lenalidomide (1 sample obtained between
days 5-21) with objective response and EFS.

IV. To evaluate toxicities of long-term lenalidomide use.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (Regimen A): Patients receive low-dose lenalidomide orally (PO) once daily (QD) on days
1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease
progression or unacceptable toxicity.

ARM II (Regimen B): Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment
repeats every 28 days for up to 26 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up annually for approximately 3
years.

Inclusion Criteria:

- Patients must have a body surface area (BSA) >= 0.4 m^2 at the time of study
enrollment

- Patients must have a pilocytic astrocytoma or optic pathway glioma that has relapsed,
progressed, or become refractory to conventional therapy; patients with
neurofibromatosis (NF-1) are eligible

- Patients must have histologic verification of malignancy; histologic confirmation for
patients with optic pathway gliomas will not be required

- Patients must have measurable residual disease, defined as tumor that is measurable in
two perpendicular diameters on magnetic resonance imaging (MRI); for a lesion to be
considered measurable, it must be at least twice the slice thickness on MRI (i.e.
visible on more than one slice)

- To document the degree of residual tumor, the following must be obtained:

- All patients must have a brain MRI with and without contrast (gadolinium) within
1 week prior to study enrollment; for patients on steroids, baseline MRI scans
must be performed after at least 1 week at a stable or decreasing dose of
steroids

- All patients with a history of spinal or leptomeningeal disease, and those
patients with symptoms suspicious of spinal disease, must have a spine MRI with
and without contrast (gadolinium) performed within 2 weeks prior to study
enrollment

- Patients must have a Lansky or Karnofsky performance status score of >= 60%; use
Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

- Patients must have been treated with at least one prior treatment regimen that
included carboplatin; patients who have received prior radiation therapy for this
tumor are eligible

- Patients must have recovered (to Common Toxicity Criteria [CTC] version [v.]4.0 =<
grade 1 unless indicated below) from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study, with the
exception of alopecia, weight changes and grade I or II lymphopenia

- Myelosuppressive chemotherapy: must not have received within 3 weeks of entry
onto this study (6 weeks if prior nitrosourea or mitomycin-C)

- Biologic (anti-neoplastic agent): at least 7 days after the last dose of a
biologic agent; for agents that have known adverse events occurring beyond 7 days
after administration, this period must be extended beyond the time during which
adverse events are known to occur

- Immunotherapy: at least 42 days after the completion of any type of
immunotherapy, e.g. tumor vaccines

- Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose
of a monoclonal antibody

- Radiation therapy (RT): patients must have had their last fraction of
craniospinal RT >= 6 months prior to study entry and their last fraction of focal
RT >= 4 weeks prior to study entry; if the lesion used for on-study criteria is
in the radiation field, there must be evidence of tumor progression after
radiation therapy was completed

- Study specific limitations on prior therapy:

- Patients who have received thalidomide are eligible if all acute
thalidomide-related toxicity has resolved

- Patients must not have received lenalidomide previously

- Growth factor(s): must not have received within 2 weeks of entry onto this study

- Steroids: patients who are receiving corticosteroids must be on a stable or decreasing
dose for at least 1 week prior to baseline MRI

- Peripheral absolute neutrophil count (ANC) >= 1,000/uL

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/m^2
OR a serum creatinine based on age/gender as follows:

- 0.4 mg/dL (1 month to < 6 months of age)

- 0.5 mg/dL (6 months to < 1 year of age)

- 0.6 mg/dL (1 to < 2 years of age)

- 0.8 mg/dL (2 to < 6 years of age)

- 1.0 mg/dL (6 to 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110
U/L; for the purpose of this study, the ULN for SGPT is 45 U/L

- Serum albumin >= 2 g/dL

- No evidence of dyspnea at rest and a pulse oximetry > 94% if there is clinical
indication for determination

- Patients must be able to swallow intact capsules

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Female patients who are pregnant are not eligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants while receiving protocol therapy and for 28 days after the last dose of
lenalidomide

- Female patients of childbearing potential are not eligible unless they commit to
complete abstinence or have been on 2 methods of birth control, including 1 highly
effective method and 1 additional method at the same time (unless committing to
complete abstinence of heterosexual intercourse) at least 28 days (4 weeks) prior to
study enrollment; sexually active females must also agree to remain on 2 methods of
birth control, during treatment (including during dose interruptions), and continuing
for at least 28 days after the completion of protocol therapy; examples of methods of
contraception are as follows:

- Highly effective methods (must use at least 1):

- Intrauterine device (IUD)

- Hormonal (prescription birth control pills, injections, implants)

- Tubal ligation

- Partner's vasectomy

- Additional effective methods:

- Male condom

- Diaphragm

- Cervical cap The two methods of birth control requirement applies to all
sexually active females unless they have undergone a hysterectomy or
bilateral oophorectomy

- Female patients of childbearing potential (including those who commit to complete
abstinence) are not eligible unless they agree to ongoing pregnancy testing and
counseling every 28 days about pregnancy precautions and risks of fetal exposure

- Male patients of child fathering potential are not eligible unless they have agreed to
use latex condoms during intercourse with a woman of childbearing potential while
receiving treatment and for 28 days thereafter

- Patients with a history of thromboembolism unrelated to a central line, or patients
with a known predisposition syndrome for thromboembolism are not eligible

- Patients who have an uncontrolled or untreated infection are not eligible

- Patients with known overt cardiac disease, including but not limited to a history of
myocardial infarction, severe or unstable angina, clinically significant peripheral
vascular disease, grade 2 or greater heart failure, or serious and inadequately
controlled cardiac arrhythmia are not eligible

- Patients with a significant systemic illness that is not well-controlled in the
opinion of the treating physician are not eligible
We found this trial at
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1201 Camino de Salud Northeast
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4900 Mueller Boulevard
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1600 7th Avenue
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Children's Hospital of Alabama Children
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3333 Burnet Avenue # Mlc3008
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530 Northeast Glen Oak Avenue
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4401 Penn Avenue
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3181 Southwest Sam Jackson Park Road
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40 Sunshine Cottage Road
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1540 East Hospital Drive
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450 Brookline Ave
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171 Ashley Avenue
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5841 S Maryland Ave
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4160 John R St #2122
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East Lansing, Michigan 48824
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801 7th Avenue
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1600 Southwest Archer Road
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1001 E 5th St
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Knoxville, Tennessee 37916
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601 South Rancho Drive Suite C-26
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1 Children's Way
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Principal Investigator: Michael K. Richards
Phone: 612-813-5193
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Morristown, New Jersey 07962
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Nashville, Tennessee 37232
Principal Investigator: Adam Esbenshade
Phone: 800-811-8480
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New Brunswick, NJ
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New Orleans, Louisiana 70118
Principal Investigator: Lolie C. Yu
Phone: 504-894-5377
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New Orleans, Louisiana 70121
Principal Investigator: Craig Lotterman
Phone: 888-562-4763
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New York, New York 10016
Principal Investigator: Jeffrey C. Allen
Phone: 212-263-4434
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Oak Lawn, Illinois 60453
Principal Investigator: Rebecca E. McFall
Phone: 847-723-7570
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Oakland, California 94611
Principal Investigator: Steven K. Bergstrom
Phone: 626-564-3455
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8200 Dodge St
Omaha, Nebraska 68114
(402) 955-5400
Principal Investigator: Minnie Abromowitch
Phone: 402-955-3972
Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
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Orlando, Florida 32803
Principal Investigator: Fouad M. Hajjar
Phone: 407-303-5623
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Orlando, Florida 32806
Principal Investigator: Vincent F. Giusti
Phone: 321-841-7743
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Rochester, Minnesota 55905
Principal Investigator: Amulya A. Nageswara Rao
Phone: 507-538-7623
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Sacramento, CA
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Sacramento, California 95819
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Saint Louis, Missouri 63104
Principal Investigator: William S. Ferguson
Phone: 314-268-4000
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