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Combination Therapy for Glioblastoma

Phase 1

Waitlist Available

Led By Michael Dominello, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

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

Must have

Histologically confirmed newly diagnosed grade IV glioma (gliosarcoma allowed)

Female subjects of childbearing potential must practice at least one of the methods of birth control listed during study entry, for the entire duration of the study and for at least 6 months after treatment with temozolomide and chloroquine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 3 months of adjuvant therapy phase

Awards & highlights

Study Summary

This trial is studying the side effects of using partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy to treat patients with newly diagnosed glioblastoma.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma who have recovered from surgery without complications. They must not have had previous chemotherapy or radiosensitizers for head and neck cancers (except certain conditions), no severe heart disease, eye disorders, or other major illnesses that could interfere with the treatment. Women of childbearing potential must use effective contraception and have a negative pregnancy test.Check my eligibility

What is being tested?

The study tests the combination of partial brain radiation therapy, temozolomide (a chemotherapy drug), chloroquine (an antimalarial drug thought to enhance cancer treatments), and tumor treating fields therapy (TTF) which uses electric fields to disrupt cancer cell growth in patients with glioblastoma.See study design

What are the potential side effects?

Possible side effects include fatigue, skin irritation from radiation, nausea from chemotherapy, vision changes due to chloroquine, and scalp irritation from TTF. There may also be an increased risk of infections and blood-related issues such as low counts of white cells or platelets.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a grade IV brain tumor.

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I am using birth control as required, if I can have children.

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I am able to care for myself but may not be able to do active work.

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I am a woman able to have children and have a recent negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 3 months of adjuvant therapy phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 3 months of adjuvant therapy phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 3 months of adjuvant therapy phase for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of patients who develop a specific acute toxicity (dermatitis)

Secondary outcome measures

Incidence of adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, temozolomide, chloroquine, TTF)Experimental Treatment5 Interventions

Patients undergo 30 fractions of 3D CRT or Intensity-modulated radiation therapy (IMRT) and receive temozolomide by mouth (PO) and chloroquine PO daily from day 1 for the duration of radiation therapy up to day 49. Treatment continues in the absence of disease progression or unacceptable toxicity. ADJUVANT TREATMENT: Beginning 4 weeks after the last day of radiation therapy, patients receive temozolomide PO QD on days 1-5 and chloroquine PO daily on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients demonstrating continued benefit may continue to receive temozolomide and chloroquine for up to 12 cycles. Patients also undergo TTF therapy over 18 hours or longer per day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chloroquine

2006

Completed Phase 4

~4690

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7230

Temozolomide

2010

Completed Phase 3

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,254 Total Patients Enrolled

2 Trials studying Glioblastoma

20 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,852 Total Patients Enrolled

322 Trials studying Glioblastoma

23,113 Patients Enrolled for Glioblastoma

Michael Dominello, M.D.Principal InvestigatorBarbara Ann Karmanos Institute

Media Library

3-Dimensional Conformal Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04397679 — Phase 1

Glioblastoma Research Study Groups: Treatment (radiation therapy, temozolomide, chloroquine, TTF)

Glioblastoma Clinical Trial 2023: 3-Dimensional Conformal Radiation Therapy Highlights & Side Effects. Trial Name: NCT04397679 — Phase 1

3-Dimensional Conformal Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397679 — Phase 1

Frequently Asked Questions

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

Has this research ever been done before?

"Currently, 212 trials of 3-Dimensional Conformal Radiation Therapy are active in 937 cities and 43 nations. This clinical trial was first initiated by Schering-Plough back in 2002 with 60 participants to achieve Phase 2 drug approval status. In the two decades that have followed, 396 additional studies on this therapy have been completed."

Answered by AI

What conditions are ameliorated by 3-Dimensional Conformal Radiation Therapy?

"3-Dimensional Conformal Radiation Therapy can be prescribed as a course of treatment for glioblastoma multiforme (GBM), actinic prurigo, and rheumatoid arthritis."

Answered by AI

What other investigations have been undertaken concerning 3-Dimensional Conformal Radiation Therapy?

"At the moment, 212 studies are underway to investigate 3-Dimensional Conformal Radiation Therapy. 24 of these experiments have advanced to Phase 3. Although research is concentrated in Seoul, Songpa there are 4763 other sites running clinical trials for this treatment."

Answered by AI

Is 3-Dimensional Conformal Radiation Therapy a risk-free treatment option?

"Our team at Power has assigned 3-Dimensional Conformal Radiation Therapy a safety score of 1 as it is currently classified in Phase 1 clinical trials. This means there is limited data available regarding efficacy and precautionary measures."

Answered by AI

What is the total number of individuals involved in this medical experiment?

"Affirmative. According to the information shared on clinicaltrials.gov, this medical research endeavour is actively seeking volunteers. The trial was initially put up for consideration on August 12th 2021 and has been recently updated on September 9th 2022. A total of 10 participants are being recruited from a single site in order to complete the study's conditions."

Answered by AI

Is this trial still looking for participants?

"This study is still open to recruitment, as indicated on clinicaltrials.gov. It was initially posted on August 12th 2021 and the latest update came out on September 9th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Michael Dominello 2021. "Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04397679.

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