Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
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|ClinicalTrials.gov Identifier: NCT01553149|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2012
Last Update Posted : June 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1 Recurrent Childhood Pilocytic Astrocytoma Recurrent Childhood Visual Pathway Glioma||Drug: Lenalidomide Other: Pharmacological Study||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||March 19, 2012|
|Actual Primary Completion Date :||June 30, 2020|
Experimental: Arm I (low-dose lenalidomide)
Patients receive low-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.
Other: Pharmacological Study
Experimental: Arm II (high-dose lenalidomide)
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.
Other: Pharmacological Study
- Objective response - best response [ Time Frame: 26 cycles of chemotherapy - up to 3 years after enrollment ]A patient who demonstrates complete response or partial response according to COG brain tumor response criteria will be considered a responder.
- Early progression [ Time Frame: Up to 180 days after enrollment ]A patient who demonstrates disease progression in the first six months of protocol therapy will be considered as demonstrating early progression.
- Time to treatment failure (event-free survival [EFS]) [ Time Frame: Up to 3 years after study enrollment ]EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
- Time to death (overall survival [OS]) [ Time Frame: Up to 3 years after study enrollment ]OS is calculated as the time from study enrollment to death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored for OS at that time.
- Incidence of toxic events defined as one in which a patient has two dose reductions and then experiences another significant toxicity using Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: While receiving protocol therapy up to 3 years after study enrollment ]A patient who experiences two dose reductions will be considered as experiencing a toxic event of interest.
- Pharmacokinetic parameters of lenalidomide [ Time Frame: Between days 5-21 of course 1 and each dose reduction ]Concentration of lenalidomide obtained from any day between day 5 and 21 of the first cycle of chemotherapy in nanograms per mL.
- Magnetic resonance imaging sequence [ Time Frame: Up to 3 years ]Response categories (complete response, partial response, stable disease, and progression) will be determined from the following three standard magnetic resonance sequences, T2-weighted, fluid attenuated inversion recovery, T1-weighted post-contrast. Percent agreement between the sequences will be estimated as the number of follow-up scans in which the corresponding sequence agreed divided by the total number of follow-up scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553149
|Principal Investigator:||Katherine E Warren||Children's Oncology Group|