Lenalidomide Dosing for Brain Tumor

Recruiting in Palo Alto (17 mi)

+129 other locations

Overseen byKatherine E Warren

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for young patients with recurrent, refractory, or progressive pilocytic astrocytoma or optic pathway glioma. They must have had prior carboplatin treatment and be able to swallow capsules. Pregnant or breastfeeding females can't join; others must use strict birth control. Patients need a minimum body surface area, specific blood counts, organ function levels, and no uncontrolled infections or significant systemic illnesses.

Inclusion Criteria

You must have a body surface area (BSA) of at least 0.4 square meters when you join the study.

If you have a history of spinal or leptomeningeal disease, or if you have symptoms that suggest spinal disease, you need to have a spine MRI with and without contrast (gadolinium) done within 2 weeks before joining the study.

You have already been treated with a medication containing carboplatin or have received radiation therapy for this tumor.

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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

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Treatment Details

Interventions

Lenalidomide (Immunomodulatory Drug)

Trial OverviewThe study compares low-dose versus high-dose Lenalidomide in treating juvenile brain tumors that are growing despite previous treatments. Lenalidomide aims to boost the immune system and may hinder tumor growth by cutting off its blood supply. The effectiveness of different doses is being evaluated.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (high-dose lenalidomide)Experimental Treatment2 Interventions

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.

Group II: Arm I (low-dose lenalidomide)Experimental Treatment2 Interventions

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.

Lenalidomide is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Revlimid for: