CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Lenalidomide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01553149
NCT01553149Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Mar 14, 2012·Updated Jan 7, 2025

In Brief

A Phase 2 clinical trial evaluating Lenalidomide and Pharmacological Study for Neurofibromatosis Type 1 and 2 related conditions. Completed, enrolled 75 participants across 126 sites in 4 countries.

Detailed Summary

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 is classified as an immunomodulatory drug as it boosts the immune system. It has other potential anti-tumor effects, for example, it 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2012
Enrollment StartJul 5, 2012
Primary CompletionJun 30, 2020
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 14.3 years ago

Interventions

Lenalidomidedrug

Given PO

Pharmacological Studyother

Correlative studies