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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 belowSelect...
My treatment with temozolomide follows FDA guidelines.
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I have been diagnosed with a grade IV brain tumor (glioblastoma or gliosarcoma).
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My glioblastoma is unmethylated according to the MGMT status test.
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I have been on a stable or decreasing dose of steroids for at least 5 days before my brain MRI.
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My kidney function, measured by creatinine or GFR, is within the required range.
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My liver function tests are within the required range.
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I finished radiation and TMZ therapy without my cancer getting worse.
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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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,689 Total Patients Enrolled
42 Trials studying Glioblastoma
1,877 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,061 Total Patients Enrolled
322 Trials studying Glioblastoma
23,023 Patients Enrolled for Glioblastoma
Shiao-Pei S WeathersPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
161 Total Patients Enrolled
3 Trials studying Glioblastoma
111 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment with temozolomide follows FDA guidelines.I am not on any medication known to affect heart rhythm.I agree to use birth control during the study.I had surgery for my brain tumor and haven't received any treatment since.I have not had another cancer or a progressing cancer needing treatment in the last 3 years.I have had specific treatments like brachytherapy or chemotherapy implants for my condition.I do not have any serious health issues that would prevent me from following the study's procedures.I have a history of HIV or active hepatitis B or C.I missed doses of temozolomide or had a low platelet count during treatment.I am not pregnant and will use birth control during the study.I will have surgery and no further treatment for my condition.I have had chemotherapy or targeted therapy recently.I have been diagnosed with a grade IV brain tumor (glioblastoma or gliosarcoma).My glioblastoma is unmethylated according to the MGMT status test.I have been on a stable or decreasing dose of steroids for at least 5 days before my brain MRI.My kidney function, measured by creatinine or GFR, is within the required range.My liver function tests are within the required range.I finished radiation and TMZ therapy without my cancer getting worse.I do not have an active infection needing treatment or a history of bleeding within my tumor.I don't have any health issues that could affect the trial's outcome.I cannot have MRIs or take certain medications due to health reasons.I am mostly able to care for myself but may need occasional help.I have not received a live vaccine in the last 30 days.I do not have severe heart failure or uncontrolled irregular heartbeats.I have abnormal potassium and magnesium levels, or cancer that has spread to my brain or other parts of my body.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 (tinostamustine)
- Group 2: Stage 2 (RT, tinostamustine)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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