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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 February 2023
• Main ID: NCT01553149
• Date of registration: 10/03/2012
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
• Scientific title: A Phase II Randomized Trial of Lenalidomide (NSC # 703813) in Pediatric Patients With Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas
• Date of first enrolment: March 19, 2012
• Target sample size: 75
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01553149
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Katherine E Warren
• Affiliation: Children's Oncology Group

Key inclusion & exclusion criteria

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 female


Age minimum: N/A
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent Childhood Pilocytic Astrocytoma

Recurrent Childhood Visual Pathway Glioma

Neurofibromatosis Type 1

Intervention(s)

Other: Pharmacological Study

Drug: Lenalidomide

Primary Outcome(s)

Number of Patients Who Demonstrate Early Progression [Time Frame: Up to 180 days after enrollment]

Number of Patients Who Demonstrate Complete or Partial Response [Time Frame: 26 cycles of chemotherapy - up to 3 years after enrollment]

Secondary Outcome(s)

Event-free Survival [EFS] [Time Frame: Up to 3 years after study enrollment]

Number of Patients With Toxic Events After 2 Dose Reductions [Time Frame: While receiving protocol therapy up to 3 years after study enrollment]

Overall Survival [OS] [Time Frame: Up to 3 years after study enrollment]

Pharmacokinetic Parameters of Lenalidomide [Time Frame: Between days 5-21 of course 1 and each dose reduction]

Magnetic Resonance Imaging Sequence [Time Frame: Up to 3 years]

Secondary ID(s)

U10CA098543

ACNS1022

CDR0000728296

COG-ACNS1022

NCI-2012-00703

s12-02726

U10CA180886

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01553149