NCT01222754

Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas

Completed Phase 1 Last updated 3 January 2022

What this trial tests

Phase 1 trial testing Lenalidomide in Diffuse Intrinsic Pontine Glioma in 29 participants. Completed in 17 April 2019.

Timeline

23 November 2010

Primary endpoint
17 April 2019

17 April 2019

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	23 November 2010
Primary completion	17 April 2019
Estimated completion	17 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Lenalidomide — full drug profile →
• XRT, 54-59.4 Gy

Conditions studied

• Diffuse Intrinsic Pontine Glioma — all drugs for Diffuse Intrinsic Pontine Glioma →
• Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →
• High Grade Glioma — all drugs for High Grade Glioma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 1 to 21, any sex, with Diffuse Intrinsic Pontine Glioma or Anaplastic Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Children who are diagnosed with brain tumors known as high grade gliomas or diffuse intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy. However, these tumors are very difficult to cure, and the tumor frequently begins to grow again even after treatment or surgery. Researchers are interested in determining whether the anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer, is a safe and effective additional treatment for children who are scheduled to receive radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.

Objectives:

\- To determine the safety and effectiveness of lenalidomide, in conjunction with radiation therapy, as a treatment for children who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas.

Eligibility:

\- Children and adolescents up to 21 years of age who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.

Design:

* Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies.
* Participants will have two phases of treatment: a lenalidomide plus radiation phase and a lenalidomide-only phase.
* During the radiation phase, participants will take lenalidomide daily and have 6 weeks of radiation therapy (five treatments per week). After the radiation therapy, participants will stop taking lenalidomide for 2 weeks before continuing to the next phase.
* During the lenalidomide-only phase, participants will take lenalidomide daily for 21 days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants will have up to 24 cycles of lenalidomide.
* Participants will have frequent blood tests during the first cycle of treatment, and will have imaging studies or other tests as required by the study researchers.
* Treatment will continue until the disease progresses, the participant chooses to leave the study, or the researchers end the study.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic strategies for diffuse midline glioma from high-throughput combination drug screening.
   Lin GL, Wilson KM, Ceribelli M, Stanton BZ, et al · · 2019 · cited 158× · PMID 31748226 · DOI 10.1126/scitranslmed.aaw0064
2. Therapeutic avenues for targeting treatment challenges of diffuse midline gliomas.
   Noon A, Galban S. · · 2023 · cited 22× · PMID 37030112 · DOI 10.1016/j.neo.2023.100899
3. The Integration of Biology Into the Treatment of Diffuse Intrinsic Pontine Glioma: A Review of the North American Clinical Trial Perspective.
   Clymer J, Kieran MW. · · 2018 · cited 15× · PMID 29868485 · DOI 10.3389/fonc.2018.00169
4. Importance of immune monitoring approaches and the use of immune checkpoints for the treatment of diffuse intrinsic pontine glioma: From bench to clinic and vice versa (Review).
   Scutti JAB. · · 2018 · cited 8× · PMID 29484440 · DOI 10.3892/ijo.2018.4283
5. A phase I trial of lenalidomide and radiotherapy in children with diffuse intrinsic pontine gliomas or high-grade gliomas.
   Hipp SJ, Goldman S, Kaushal A, Krauze A, et al · · 2020 · cited 6× · PMID 33040274 · DOI 10.1007/s11060-020-03627-0
6. Bench-to-bedside investigations of H3 K27-altered diffuse midline glioma: drug targets and potential pharmacotherapies.
   Rechberger JS, Bouchal SM, Power EA, Nonnenbroich LF, et al · · 2023 · cited 3× · PMID 37897190 · DOI 10.1080/14728222.2023.2277232
7. Pharmacological Phase I Clinical Trials in Pediatric Brain Tumors (1990-2024): A Historical Perspective.
   Scarpitta R, Cappello E, Cangialosi A, Gori V, et al · · 2025 · PMID 41050069 · DOI 10.32604/or.2025.066260