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Chemotherapy

WBRT + Temozolomide + Plerixafor for Brain Cancer

Phase 2
Recruiting
Led By Lawrence Recht
Research Sponsored by Lawrence D Recht
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.
Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing how well radiation and chemotherapy work with a new drug, plerixafor, to treat brain tumors.

Who is the study for?
This trial is for patients with high-grade gliomas, including glioblastoma. They must have had surgery but no other cancer treatments and should be in good enough health to understand the study and give consent. Key requirements include normal liver function tests, adequate kidney function, a negative pregnancy test for women of childbearing age, and an agreement to use effective contraception.Check my eligibility
What is being tested?
The study is testing if adding Plerixafor to standard treatment (Temozolomide chemo-radiotherapy) along with Whole Brain Radiation Therapy improves outcomes in glioblastoma patients. It's a phase II trial aiming to see how well these combined therapies work at killing tumor cells or stopping their growth.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation like skin irritation and fatigue; chemotherapy-related issues such as nausea, low blood counts leading to increased infection risk; and possible effects from Plerixafor like injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a high-grade glioma, such as glioblastoma.
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I've had surgery for my cancer and haven't received any other cancer treatments except for the specified chemo-radiation.
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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Progression-free survival (PFS) at six months
Secondary outcome measures
Median Survival
Patterns of treatment failure
Toxicity associated with Plerixafor/WBRT

Trial Design

1Treatment groups
Experimental Treatment
Group I: Whole Brain Radiotherapy + Plerixafor +ChemoradiotherapyExperimental Treatment4 Interventions
After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~720
Temozolomide
2010
Completed Phase 3
~1930
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Lawrence D RechtLead Sponsor
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,960 Total Patients Enrolled
3 Trials studying Glioblastoma
220 Patients Enrolled for Glioblastoma
Lawrence RechtPrincipal InvestigatorStanford Cancer Institute Palo Alto
2 Previous Clinical Trials
39 Total Patients Enrolled
1 Trials studying Glioblastoma
30 Patients Enrolled for Glioblastoma

Media Library

Temozolomide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03746080 — Phase 2
Glioblastoma Research Study Groups: Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy
Glioblastoma Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT03746080 — Phase 2
Temozolomide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03746080 — Phase 2

Frequently Asked Questions

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

Does Radiation Therapy have potential long-term side effects?

"While there is some data supporting the safety of Radiation Therapy, it did not receive a high score because Phase 2 trials have yet to produce evidence of efficacy."

Answered by AI

Does this research involve elderly individuals?

"As specified, individuals that meet the age requirements of 18-75 years old are eligible to participate in this clinical trial."

Answered by AI

Are there any current openings for people who want to participate in this trial?

"This trial is still looking for participants, as indicated by the listing on clinicaltrials.gov. The study was first posted on December 4th 2018 and updated July 7th 2022."

Answered by AI

Are there other instances where Radiation Therapy has been used in a research capacity?

"Presently, there are 236 ongoing studies investigating Radiation Therapy with 25 of them being Phase 3 trials. Most of the research for this treatment is based in Boston, but there are 4882 total locations running trials for Radiation Therapy."

Answered by AI

What types of cancer does Radiation Therapy typically treat?

"Although most often used to combat disease progression, radiation therapy can also be useful in treating other conditions such as nitrosourea treatment, advanced directives, and refractory mycosis fungoides."

Answered by AI

How can I become a test subject for this research?

"This study is enrolling 20 patients with glioblastoma, between the ages of 18 and 75. The following criteria must also be met: Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, or glioblastoma with primitive neuroectodermal tumor (PNET) features., If female of childbearing potential, negative pregnancy test (at time of screening)., Patient should have surgery (biopsy,"

Answered by AI

Is this a precedent-setting clinical trial?

"There are 236 ongoing clinical trials involving Radiation Therapy in 38 countries and 949 cities. The first such trial began in 2002 and, upon completion of Phase 2 drug approval, involved 60 patients. In the 18 years since that initial study 472 more have been conducted."

Answered by AI

How many people are participating in this test of the new medication?

"That is correct, the study detailed on clinicaltrials.gov is currently looking for 20 additional patients from 1 medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
Lawrence D Recht 2018. "Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03746080.
All > Recurrent Glioblastoma > Oligodendroglioma
~3 spots leftby Apr 2025
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