58 Participants Needed

Dabrafenib + Trametinib After Radiation for Brain Cancer

Recruiting at 137 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how well dabrafenib and trametinib work after radiation therapy in children and young adults with a specific type of brain tumor. These drugs help stop tumor growth by blocking signals that tell the cells to multiply. Dabrafenib has been developed and tested extensively for a specific type of skin cancer, showing effectiveness both alone and when used with trametinib.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a seizure disorder, you can participate if your seizures are well controlled with non-enzyme inducing anticonvulsants. It's best to discuss your specific medications with the trial team.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients with a seizure disorder can participate if their seizures are well controlled on non-enzyme inducing anticonvulsants, which suggests some medications may be allowed. It's best to discuss your specific medications with the trial team.

What safety data exists for Dabrafenib + Trametinib after radiation for brain cancer?

The provided research does not directly address the safety data for Dabrafenib + Trametinib after radiation for brain cancer. However, it includes studies on the safety and toxicity of various radiotherapy techniques, such as stereotactic radiotherapy (SRT), intensity-modulated radiotherapy (IMRT), and image-guided radiotherapy (IGRT), in different cancer treatments. These studies highlight the importance of advanced radiotherapy techniques in reducing toxicity, but specific safety data for the combination of Dabrafenib and Trametinib with radiation therapy for brain cancer is not covered in the provided abstracts.12345

Is the combination of Dabrafenib, Trametinib, and various forms of radiotherapy generally safe for humans?

Research shows that advanced radiotherapy techniques like intensity-modulated radiotherapy (IMRT) and stereotactic body radiation therapy (SBRT) are generally safe, with some risk of gastrointestinal and genitourinary side effects. These techniques have been used safely in treating various cancers, including prostate and cervical cancer.12345

Is Radiation Therapy a promising treatment for brain cancer when used with Dabrafenib and Trametinib?

Radiation Therapy, when combined with the drugs Dabrafenib and Trametinib, shows promise for treating brain cancer. This combination has been effective in treating other cancers with similar mutations, and early studies suggest it could work well for brain tumors too.678910

How is the treatment of Dabrafenib + Trametinib after radiation therapy unique for brain cancer?

This treatment combines radiation therapy with two drugs, Dabrafenib and Trametinib, which target specific mutations (BRAF V600E) in brain tumors. This approach is unique because it combines targeted drug therapy with radiation, potentially enhancing effectiveness against certain brain cancers with specific genetic mutations.678910

What data supports the idea that Dabrafenib + Trametinib After Radiation for Brain Cancer is an effective treatment?

The available research does not provide specific data on the effectiveness of Dabrafenib + Trametinib after radiation for brain cancer. The studies focus on different radiotherapy techniques and their advancements, but they do not directly address the combination of Dabrafenib and Trametinib with radiation for brain cancer. Therefore, we cannot conclude its effectiveness based on the provided information.211121314

What data supports the effectiveness of the treatment Dabrafenib + Trametinib after radiation for brain cancer?

Research shows that advanced radiotherapy techniques like intensity-modulated radiotherapy (IMRT) and stereotactic radiosurgery can improve outcomes for brain tumors by precisely targeting cancer cells while sparing healthy tissue. These methods are part of the treatment plan in the trial, suggesting potential effectiveness in combination with Dabrafenib and Trametinib.211121314

Who Is on the Research Team?

RR

Rishi R Lulla

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for children and young adults aged between 1 to 21 years with newly-diagnosed high-grade glioma that has a specific genetic change (BRAF V600 mutation). They must not have had any previous tumor-directed therapy other than surgery or corticosteroids, should be in good health otherwise, and able to follow the study procedures. Pregnant or breastfeeding females are ineligible, as well as those with certain medical conditions like uncontrolled heart disease.

Inclusion Criteria

My tumor tested positive for H3 K27M mutation.
I can take care of myself but may not be able to do active work.
My spinal fluid test was negative for cancer cells.
See 20 more

Exclusion Criteria

I have no allergies to dabrafenib, trametinib, or similar medications.
I do not have a tumor in my brainstem or spinal cord.
I have a history or current issue with specific eye conditions (RVO or CSR) or risk factors for them.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo standardized local radiation therapy 5 days a week (Monday-Friday) for 6-7 weeks

6-7 weeks
5 visits per week (in-person)

Treatment

Patients receive dabrafenib mesylate orally twice daily and trametinib dimethyl sulfoxide once daily on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles

Up to 24 months
Regular visits for MRI and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with MRI and other assessments

Up to 5 years
Every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then annually for years 4-5

What Are the Treatments Tested in This Trial?

Interventions

  • Dabrafenib, Trametinib
  • Radiation Therapy
Trial Overview The trial tests how well dabrafenib combined with trametinib works after radiation therapy in patients with BRAF V600-mutant high-grade glioma. Dabrafenib targets the BRAF enzyme while trametinib targets MEK; both enzymes are involved in tumor cell growth. The goal is to see if this combination improves outcomes compared to past treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, dabrafenib, trametinib)Experimental Treatment6 Interventions

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Radiation Therapy for:
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Approved in United States as Radiation Therapy for:
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Approved in Canada as Radiation Therapy for:
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Approved in Japan as Radiation Therapy for:
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Approved in China as Radiation Therapy for:
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Approved in Switzerland as Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 92 patients with brain metastases, low-dose whole brain radiation therapy (WBRT) combined with simultaneous integrated boost (SIB) achieved a local brain control rate of 72%, which was higher than conventional WBRT (56%) and comparable to stereotactic IMRT (78%).
The SIB technique also demonstrated a high distant brain control rate of 92%, indicating its effectiveness in preventing new brain metastases, while showing a low incidence of toxicity, with only one case of radionecrosis reported.
Early clinical outcomes for 3 radiation techniques for brain metastases: focal versus whole-brain.Vargo, JA., Plants, BA., Mihailidis, DN., et al.[2016]
Intensity-modulated stereotactic radiotherapy (IMSRT) provides better conformity and coverage for planning target volumes (PTV) compared to stereotactic conformal radiotherapy (SCRT), especially for irregular and multifocal lesions, based on a study of 10 patients.
IMSRT also offers improved sparing of organs at risk (OAR), resulting in lower doses to these critical areas, although it may increase the volume of normal tissue receiving a low dose.
Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base.Baumert, BG., Norton, IA., Davis, JB.[2022]
In a study of 379 patients with non-metastatic Stage III-IV head and neck squamous cell cancer, IMRT with simultaneous integrated boost (IMRT+SIB) showed similar effectiveness in local control and survival rates compared to traditional 3D conformal radiotherapy (3D-CRT) and sequential IMRT (IMRTseq).
IMRT+SIB significantly reduced acute toxicity, with lower rates of severe mucositis, dermatitis, and the need for feeding tubes during treatment, suggesting it is a safer option for patients undergoing chemoradiation.
Comparison of 3D confromal radiotherapy and intensity modulated radiotherapy with or without simultaneous integrated boost during concurrent chemoradiation for locally advanced head and neck cancers.Spiotto, MT., Weichselbaum, RR.[2021]

Citations

Early clinical outcomes for 3 radiation techniques for brain metastases: focal versus whole-brain. [2016]
Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. [2022]
Comparison of 3D confromal radiotherapy and intensity modulated radiotherapy with or without simultaneous integrated boost during concurrent chemoradiation for locally advanced head and neck cancers. [2021]
Improving radiotherapy for brain tumors. [2005]
Radiotherapy for brain tumors. [2019]
Toxicity and time lapse between immunotherapy and stereotactic radiotherapy of brain metastases. [2021]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]
Radiotherapy of Cervical Cancer. [2017]
Current use of stereotactic body radiation therapy for low and intermediate risk prostate cancer: A National Cancer Database Analysis. [2021]
Phase I study of trametinib in combination with whole brain radiation therapy for brain metastases. [2023]
Cerebral infarction after treatment with dabrafenib plus trametinib for BRAF-V600E-positive non-small cell lung cancer: A case report. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Dual BRAF/MEK therapy in BRAF V600E-mutated primary brain tumors: a case series showing dramatic clinical and radiographic responses and a reduction in cutaneous toxicity. [2023]
Treatment related toxicities with combination BRAF and MEK inhibitor therapy in resected stage III melanoma. [2022]
Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study. [2022]
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