← Back to Search

Alkylating agent

Tinostamustine + Radiation Therapy for Glioblastoma

Phase 1

Waitlist Available

Led By Shiao-Pei S Weathers

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed treatment with concomitant temozolomide must be consistent with the FDA package insert and meet specified dosing criteria

Have histologically confirmed World Health Organization grade IV glioma (glioblastoma [GB] or gliosarcoma)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying the side effects and best dose of a drug called tinostamustine, given with or without radiation therapy, in treating patients with newly diagnosed glioblastoma that does not have a gene mutation called MGMT-unmethylated. Tinostamustine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with newly diagnosed MGMT-unmethylated glioblastoma who have completed standard radiation therapy without disease progression. They must not have had prior chemotherapy, be HIV positive, or have certain heart conditions. Women of childbearing potential and men must agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the effects and optimal dosage of Tinostamustine, alone or combined with radiation therapy, on tumor growth in patients with a specific type of brain cancer called glioblastoma that lacks a certain DNA repair mechanism (MGMT unmethylation).See study design

What are the potential side effects?

Potential side effects include reactions related to cell growth inhibition which may affect blood counts leading to anemia or increased infection risk, liver function changes, and possibly other organ-related issues due to enzyme blockage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My treatment with temozolomide follows FDA guidelines.

Select...

I have been diagnosed with a grade IV brain tumor (glioblastoma or gliosarcoma).

Select...

My glioblastoma is unmethylated according to the MGMT status test.

Select...

I have been on a stable or decreasing dose of steroids for at least 5 days before my brain MRI.

Select...

My kidney function, measured by creatinine or GFR, is within the required range.

Select...

My liver function tests are within the required range.

Select...

I finished radiation and TMZ therapy without my cancer getting worse.

Select...

I am mostly able to care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) (Stages 1 & 2)

Secondary outcome measures

Incidence of adverse events (Stage 1)

Objective response rate (ORR) (Stage 2)

Overall survival (OS) (Stage 2)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage 2 (RT, tinostamustine)Experimental Treatment2 Interventions

Patients who have received no treatment other than surgery undergo RT 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive tinostamustine over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Stage 1 (tinostamustine)Experimental Treatment1 Intervention

Patients who have completed TMZ and RT receive tinostamustine IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 8Eligibility criteria met