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Alkylating agents

VAL-083 for Glioblastoma

Phase 2

Waitlist Available

Led By Barbara O'Brien, M.D.

Research Sponsored by Kintara Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must be ≥ 18 years old.

Patients having prior therapy with Laser Induced Thermal Therapy (LITT) is allowed, but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 predose, 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of iv infusion of val-083

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it can improve overall survival for people with a certain type of brain cancer.

Who is the study for?

This trial is for adults over 18 with a specific brain cancer called glioblastoma, which hasn't been treated with bevacizumab. Their tumors must not have a certain DNA feature (MGMT unmethylated) and they should be in good physical condition (KPS > 60%). They need to have finished any chemotherapy at least 4 weeks prior and recovered from recent surgeries or treatments.Check my eligibility

What is being tested?

The study tests VAL-083, also known as Dianhydrogalactitol, to see if it improves survival for patients with glioblastoma compared to past data. It's designed for those who are either newly diagnosed or experiencing recurrence of their brain tumor.See study design

What are the potential side effects?

While the specific side effects of VAL-083 aren't listed here, similar chemotherapy drugs can cause fatigue, nausea, hair loss, blood cell changes increasing infection risk, and nerve damage leading to numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I had Laser Induced Thermal Therapy 21 days ago or more, with minimal side effects and confirmed cancer return.

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I am mostly independent and can care for myself.

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I have recovered from recent surgery with minimal side effects.

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My initial diagnosis was a type of brain tumor called glioblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 predose, 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of iv infusion of val-083

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 predose, 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of iv infusion of val-083

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 predose, 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of iv infusion of val-083 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Survival

Secondary outcome measures

Estimate Duration of Response

Estimate Median Overall Survival

Estimate Median Progression-Free Survival

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: VAL-083, Dianhydrogalactitol (Group 2)Experimental Treatment1 Intervention

Newly diagnosed GBM patients who have completed chemoradiation treatment with temozolomide and received no subsequent maintenance temozolomide

Group II: VAL-083, Dianhydrogalactitol (Group 1)Experimental Treatment1 Intervention

Patients with recurrent/progressive GBM

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kintara Therapeutics, Inc.Lead Sponsor

4 Previous Clinical Trials

1,075 Total Patients Enrolled

2 Trials studying Glioblastoma

1,060 Patients Enrolled for Glioblastoma

Barbara O'Brien, M.D.Principal InvestigatorUniversity of Texas, MDAnderson Cancer Center, Houston, Texas, USA 77030

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being enrolled into this research experiment?

"Records on clinicaltrials.gov signify that this investigation is no longer recruiting participants, as the most recent update was posted in September 2022 and it first debuted in January 2017. However, there are currently 1036 other active studies accepting enrollees."

Answered by AI

Are there any additional investigations into the efficacy of VAL-083 and Dianhydrogalactitol for therapeutic use?

"Currently, two scientific trials are underway for VAL-083, Dianhydrogalactitol (Group 1), with one in the third phase. Miami is home to multiple studies while a total of 50 trial sites exist globally."

Answered by AI

Is this a revolutionary clinical trial?

"Since 2017, VAL-083 Dianhydrogalactitol (Group 1) has undergone clinical research. Kintara Therapeutics, Inc. sponsored the first trial in 2017 with 119 participants; subsequently it was approved for a Phase 2 drug status. Currently there are two active trials available across 37 cities and 4 nations."

Answered by AI

How many participants are enrolled in this trial?

"This clinical trial is not currently accepting candidates. The study's initial post date was January 20th 2017 and the most recent update occured on September 22nd 2022. For those exploring other studies, there are 1034 current trials seeking participants with glioblastoma and 2 VAL-083 Dianhydrogalactitol (Group 1) focused medical investigations that are actively taking enrolment."

Answered by AI

What has been revealed about the security profile of VAL-083, Dianhydrogalactitol (Group 1)?

"Our panel of experts at Power rated the safety profile of VAL-083, Dianhydrogalactitol (Group 1) as a 2. This assessment is based on Phase 2 clinical trials that have presented evidence in support of its safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting

2017. "Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02717962.