A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Overview

About this study

The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients must be ≥ 2 years and ≤ 25 years of age at the time of enrollment on Step 0.
  • All patients > 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age. 
  • Patient is suspected of having progressive or recurrent low-grade glioma (LGG).
  • Patient does not have a known diagnosis of neurofibromatosis type 1 (NF1) or tuberous sclerosis complex (TSC).
  • Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.

Exclusion Criteria:

  • Prior therapy with vinblastine and/or a MEK inhibitor is permitted, with the following exceptions:
    • Patients must not have had progressive disease while on therapy with vinblastine or a MEK inhibitor;
    • Patients must not have discontinued vinblastine or selumetinib due to toxicity.
  • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year.
  • Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals Grade I/II histology.
  • Patients may not be receiving any other investigational agents.
  • Patients must not have known hypersensitivity to selumetinib, vinblastine, or similar compounds.
  • CYP3A4 Agents: Patients must not have received fluconazole or drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment.
  • Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment.
  • Patients who, in the opinion of the investigator, are not able to comply with the study procedures.
  • Surgery within 2 weeks prior to enrollment, with the exception of a surgical biopsy, placement of a vascular access device or CSF diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.
    • Note: Patients must have healed from any prior surgery.
  • Patients who have an uncontrolled infection.
  • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy.
    • Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Schwartz, D.O., M.P.H.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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