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AQ4N + Radiotherapy + Temozolomide for Glioblastoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Novacea

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status of > 60

Plan to begin partial brain radiotherapy within 24-72 hours after beginning AQ4N, and within 35 days (5 weeks) of the surgery, or if surgery cannot be performed, the biopsy that confirms GBM diagnosis. Radiation therapy must be given by external beam to a partial brain field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy over 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug, AQ4N, for treating Huntington's disease.

Who is the study for?

This trial is for adults over 18 with newly diagnosed Glioblastoma Multiforme (GBM) who can start radiotherapy shortly after surgery or biopsy. Participants need a life expectancy of more than 10 weeks, decent physical function, and must not be pregnant. They should have good organ function and agree to use contraception. Those with other cancers in the last two years, prior brain treatments, or recent investigational therapies cannot join.Check my eligibility

What is being tested?

The study tests AQ4N combined with radiotherapy and Temozolomide in GBM patients. Phase 1b explores safety at different doses; Phase 2a checks both safety and effectiveness at the best dose from Phase 1b.See study design

What are the potential side effects?

Specific side effects are not listed but typically include reactions related to drug tolerance levels such as fatigue, nausea, headaches, or potential liver and kidney issues due to medication toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but cannot do normal activities or work.

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I am scheduled for brain radiation soon after starting AQ4N treatment and within 5 weeks of my surgery or biopsy.

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I am 18 years or older with an expected lifespan of more than 10 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected.

Phase 2a: Rate of progression-free survival at 6 months.

Secondary outcome measures

Duration of overall survival

Duration of progression-free survival

Percent of subjects alive at 12 months

+2 more

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NovaceaLead Sponsor

10 Previous Clinical Trials

1,913 Total Patients Enrolled

Media Library

Glioblastoma Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT00394628 — Phase 1 & 2

Frequently Asked Questions

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

Are there a substantial number of centers carrying out this trial in Canada?

"This medical study is recruiting participants from 5 distinct sites, such as the Baylor Research Institute in Dallas, University of California Los Angeles, and Duke University Medical Center."

Answered by AI

Is it feasible to join this research project now?

"Unfortunately, this particular experiment is not currently engaging patients. It was initially listed on October 1st 2006 and last modified by the administrators on May 29th 2007. Nevertheless, there are 442 other trials requiring participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme

2006. "AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00394628.

All > Glioblastoma Long Beach > Paid Studies California