20 Participants Needed

Adaptive Radiotherapy for Brain Tumor

Recruiting at 1 trial location
TJ
RO
Overseen ByRadiation Oncology Research Department
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is sacituzumab govitecan safe for humans?

Sacituzumab govitecan has been studied in various cancers and generally shows a safe profile, but it can cause side effects like neutropenia (low white blood cell count), diarrhea, and fatigue. It's important to monitor for serious reactions such as colitis (inflammation of the colon) and sepsis (a severe infection) during treatment.12345

How is adaptive radiotherapy different from other treatments for brain tumors?

Adaptive radiotherapy (ART) is unique because it adjusts the treatment plan based on changes in the tumor size and position during the treatment period, which can increase precision and reduce damage to healthy tissues. This approach is different from traditional radiotherapy, which uses a fixed plan throughout the treatment.678910

What data supports the effectiveness of the drug sacituzumab govitecan for treating brain tumors?

Sacituzumab govitecan has shown effectiveness in treating various solid tumors, including breast cancer and small cell lung cancer, by targeting a protein called Trop-2 on cancer cells. It has been approved for use in metastatic triple-negative breast cancer and is being explored for other cancers, including brain metastases.2351112

Who Is on the Research Team?

TJ

Tony J. Wang, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high-grade gliomas like glioblastoma, who haven't had previous tumor treatments except biopsy or resection. They must have a Karnofsky performance status of 70+ and plan to receive standard radiotherapy. Pregnant women can't participate.

Inclusion Criteria

Females of childbearing potential must provide a negative pregnancy test prior to their first research MRI, as per institutional regulations.
I am scheduled for a specific radiotherapy plan, not a shortened course.
My diagnosis is a type of aggressive brain tumor.
See 2 more

Exclusion Criteria

I have been cancer-free for at least 2 years, except for non-melanoma skin cancer.
I have only had a biopsy or surgery for my tumor, no other treatments.
Current or planned treatment with any other investigational agents for high grade glioma
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiotherapy per standard of care over 30-33 once-daily fractions with 7 brain MRIs each week, or 15 once-daily fractions with 4 brain MRIs each week for those receiving hypofractionated radiotherapy

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Adaptive Radiotherapy
Trial Overview The study tests if extra MRI scans during the weekly radiation treatment can improve outcomes for patients with aggressive brain tumors. It aims to adapt radiotherapy more precisely to the changes in the tumor's size and shape.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Adaptive RadiotherapyExperimental Treatment1 Intervention
Subjects will receive radiotherapy per standard of care over 30-33 once-daily fractions in addition to 7 brain MRIs each in every week of treatment. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions in addition to 4 brain MRIs each in every week of treatment.

Adaptive Radiotherapy is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Trodelvy for:
  • Metastatic triple-negative breast cancer (mTNBC)
  • Metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer
  • Metastatic urothelial cancer (approval being withdrawn)
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Approved in European Union as Trodelvy for:
  • Metastatic triple-negative breast cancer (mTNBC)
  • Metastatic urothelial cancer
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Approved in Canada as Trodelvy for:
  • Metastatic triple-negative breast cancer (mTNBC)
  • Metastatic urothelial cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Varian Medical Systems

Industry Sponsor

Trials
63
Recruited
3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.
The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.
First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors.Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]
In a study of 50 patients with metastatic small cell lung cancer (mSCLC) who had been heavily pretreated, sacituzumab govitecan demonstrated a 14% objective response rate, with 60% of patients showing tumor shrinkage, indicating its potential efficacy as a treatment option.
The treatment was found to be generally safe, with manageable side effects; however, significant adverse events included neutropenia (34%) and fatigue (13%). This suggests that while effective, careful monitoring for side effects is necessary.
Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan.Gray, JE., Heist, RS., Starodub, AN., et al.[2022]
Sacituzumab govitecan (IMMU-132) demonstrated a predictable pharmacokinetic profile and manageable toxicity in patients with advanced epithelial cancers, with doses of 8 mg/kg (n=81) and 10 mg/kg (n=97) showing safety and efficacy.
The treatment resulted in objective responses in various cancer types, particularly metastatic triple-negative breast cancer, supporting the use of the 10 mg/kg dose for future clinical development.
Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics.Ocean, AJ., Starodub, AN., Bardia, A., et al.[2018]

Citations

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. [2022]
Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. [2022]
Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. [2018]
Sacituzumab Govitecan: First Approval. [2021]
Role of sacituzumab govitecan in solid tumors. [2023]
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]
Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). [2023]
Study on the Appropriate Timing of Postoperative Adaptive Radiotherapy for High-Grade Glioma. [2022]
Adaptive radiotherapy for locally advanced non-small cell lung cancer, can we predict when and for whom? [2018]
Survival benefits for non-small cell lung cancer patients treated with adaptive radiotherapy. [2022]
Stereotactic MR-Guided Radiotherapy for Pancreatic Tumors: Dosimetric Benefit of Adaptation and First Clinical Results in a Prospective Registry Study. [2022]
A prospective comparison of adaptive and fixed boost plans in radiotherapy for glioblastoma. [2022]
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