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15 Plexiform Neurofibroma Trials
Power is an online platform that helps thousands of Plexiform Neurofibroma patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
MEK Inhibitor for Neurofibromatosis
Columbus, OhioThis trial tests mirdametinib, a medication taken by mouth, for patients with NF1-related tumors that can't be surgically removed. The drug works by blocking specific proteins to stop or shrink the tumors. Mirdametinib has shown significant and lasting decreases in pain and partial responses in NF1-related plexiform neurofibromas.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:2+
Sex:All
114 Participants Needed
Binimetinib for Neurofibromatosis
Columbus, OhioThis is a phase II open label study that will evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to binimetinib in children and adults with NF1 and inoperable plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease in tumor volume reduction by 12 courses.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:1+
Sex:All
40 Participants Needed
AZD6244 for Neurofibromatosis
Cincinnati, OhioBackground:
- Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat them is with surgery. Some of these tumors cannot be completely removed. The tumors may be too large, too numerous, or in a bad location for surgery. An experimental drug called AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their growth, or shrink them. This drug has been tested in adults with cancer and in children with some types of brain cancer. This study will test how well this drug works with these types of tumors.
Objectives:
- To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young adults with plexiform neurofibromas that cannot be completely removed by surgery.
Eligibility:
- Children and young adults between 12 and 18 years of age who have plexiform neurofibromas that cannot be completely removed by surgery.
Design:
* Patients will be screened with a physical exam, medical history, blood tests, and imaging studies.
* They will take the study drug twice a day with 8 ounces of water, every day for 28-day cycles of treatment. During study visits, participants will have blood and urine tests and physical exams. They will also have imaging studies to examine the tumor sizes and locations. They will answer questions about their health. They may have other tests as needed.
* Participants will continue to receive the study drug as long as they have no severe side effects and the disease is not getting worse.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 18
Sex:All
99 Participants Needed
HLX-1502 for Neurofibromatosis
Cincinnati, OhioThe trial will be an open label, single arm, phase 2 study in 20 participants. The study will assess the tolerability and efficacy of HLX-1502 in participants with NF1 16 years of age or older with progressive and/or symptomatic PN.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:16+
Sex:All
Key Eligibility Criteria
Disqualifiers:NF1-related Tumors, Cardiovascular Disorders, Others
Must Not Be Taking:MEK-inhibitors, TKI Drugs
20 Participants Needed
Dabrafenib + Trametinib for Brain Tumors
Cincinnati, OhioThis trial is studying the effects of two cancer medications, dabrafenib and trametinib, in children. These drugs work by stopping signals that make cancer cells grow. Dabrafenib and trametinib have shown benefits in various BRAF-mutant tumors, including melanoma, lung cancer, and thyroid cancer. The goal is to see how these treatments affect children over time.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:1 - 99
Sex:All
164 Participants Needed
Selumetinib for Plexiform Neurofibroma
Akron, OhioThis trial is testing how well selumetinib works when taken with a low-fat meal in adolescents with NF1 who have tumors that can't be removed by surgery. The goal is to see if eating a low-fat meal affects how the body absorbs the medication and if it helps reduce stomach-related side effects. Selumetinib is being investigated for its effectiveness in treating NF1-associated tumors, with previous studies showing promising positive results in patients.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:12 - 17
Sex:All
24 Participants Needed
FCN-159 for Neurofibromatosis
Detroit, MichiganThis trial is testing FCN-159, a new drug taken by mouth, for patients with advanced solid tumors and neurofibromatosis type 1. The drug works by blocking specific proteins that help cancer cells grow. This targeted approach aims to slow down or stop the progression of these diseases.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 70
Sex:All
160 Participants Needed
Selumetinib for Plexiform Neurofibromas
Toronto, OntarioThis trial is testing a medication called selumetinib to see if it can help adults with a condition called NF1 who have tumors that cause symptoms and cannot be removed by surgery. The medication works by blocking signals that make the tumors grow.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
146 Participants Needed
Trametinib for Pediatric Brain Tumor
Toronto, OntarioThis is a phase 2, open-label, interventional clinical trial that will study the response rate of pediatric glioma and plexiform neurofibroma (PN) to oral administration of trametinib. Patients meeting all inclusion criteria for a given study group will receive the study medication at a daily dose of 0.025 mg/kg up to a total of 18 cycles, in 28-day cycles. A total of 150 patients will be recruited as part of this clinical study.
Patients aged between 1 month (corrected age) and 25 years old will be eligible, in order to include a maximum of patients affected by low-grade glioma (LGG) and PN. This study includes four groups: patients with neurofibromatosis type 1 (NF1) and LGG, NF1 patients with PN, patients with LGG with a B-Raf Serine/Threonine-protein Kinase/Proto-oncogene Encoding B-Raf (BRAF) fusion and patients with glioma of any grade with activation of the Mitogen-activated Protein Kinase/Extracellular Signal-regulated Kinases (MAPK/ERK) pathway. All patients except patients with PN must have failed at least one line of treatment.
The study will also explore the molecular mechanisms behind tumor development, progression and resistance to treatment. Furthermore, this study will also explore important aspects for patients with brain tumors by including assessment of quality of life and neuropsychological evaluation.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:1 - 25
Sex:All
114 Participants Needed
Turalio for Leukemia
Bethesda, MarylandBackground:
- Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing.
Objectives:
- To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer.
Eligibility:
- People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies.
Design:
* Participants will be screened with:
* Medical history
* Physical exam
* Blood and urine tests
* Heart tests
* Scans or other tests of the tumor
* Participants will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years.
* During the study, participants will have many tests and procedures. They include repeats of the screening tests. Participants will keep a diary of symptoms.
* Participants with solid tumors will have scans or x-rays.
* Participants with leukemia will have blood tests. They may have a bone marrow sample taken.
* Some participants may have a biopsy.
* When finished taking TURALIO(R), participants will have follow-up visits. They will repeat the screening tests and note side effects.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:3 - 35
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Hepatitis, Others
Must Not Be Taking:Warfarin, CYP3A4 Drugs
54 Participants Needed
Selumetinib for Neurofibromatosis
Bethesda, MarylandBackground:
Neurofibromatosis type 1 (NF1) is a disorder that can cause plexiform neurofibromas (PNs). These are tumors that grow along nerves. Some PNs cause serious health problems. PNs often can t be operated on because of their large size, location, or number. There are no effective treatments known for people with NF1 and PNs. Researchers want to test if the drug selumetinib (AZD6244 hydrogen sulfate) causes PNs to shrink or slows down their growth.
Objectives:
To test if selumetinib helps treat PNs. To test how the body handles selumetinib and how it affects peoples symptoms.
Eligibility:
People ages 18 and older with NF1, with an inoperable PN that causes morbidity or is growing
Design:
Participants will be screened with:
Medical history and physical exam
Blood, urine, and heart tests
Eye exam
MRI: They lie in a machine that takes pictures of the body.
PN biopsy: A small piece of the tumor is removed by a large needle.
Questionnaires
Participants will swallow selumetinib capsules every 12 hours for several 28-day cycles. The capsules are taken with a full glass of water on an empty stomach. Participants may have only water for 2 hours before and 1 hour after each dose.
Participants will keep a drug diary. They will continue taking the drug as long as they tolerate it and their disease doesn t progress.
Participants will have several visits throughout the study. These will include repeats of the screening tests.
Participants will have a final visit after they stop taking selumetinib.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
36 Participants Needed
AlgometRx Nociometer for Neurofibromatosis
Bethesda, MarylandBackground:
Neurofibromatosis type 1 (NF1) is a genetic condition that causes tumors to grow along the nerves in the skin, brain, and other parts of the body. People with NF1 often have pain and may experience other abnormal sensations like itching, numbness, or tingling. These symptoms can affect their daily life. Researchers want to learn more about these symptoms and find better ways to measure pain in people with NF1.
Objective:
To learn if a device called the AlgometRx Nociometer is effective in measuring pain or other abnormal sensations in people with NF1.
Eligibility:
People aged 1 year and older with NF1.
Design:
Participants can have up to 3 assessments completed in person. Each assessment may last up to 1.0 to 1.5 hours.
Participants will be screened. They will complete questionnaires about their health and how bad their pain is. If participants are having blood drawn for other reasons, some additional samples may be used in this study.
The AlgometRx Nociometer includes an electrode that will be placed onto a finger or a toe. The electrode will send non-painful electrical signals to activate nerves in the finger or toe. At the same time, a camera will be used to record changes in the pupil of the eye. The test will be done on all 4 of the participant s limbs; however, researchers may skip 1 or more limbs for various reasons. This test takes about 10 seconds to complete with at least a one-minute rest between testing different limbs.
Participants will be asked to do a 2nd assessment with the AlgometRx Nociometer that may be done 1 hour later but no more than 72 hours after the first assessment. Participants who will be returning for another visit can opt to do a 3rd assessment that will be done at least 4 weeks but not more than 18 months after the 1st....
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:1+
Sex:All
70 Participants Needed
Avutometinib for Solid Tumors
Atlanta, GeorgiaThe purpose of this study is to find out whether avutometinib is a safe treatment for advanced or recurrent solid tumor cancers in children and young adults. Researchers will look for the highest dose of avutometinib that is safe and cause few or mild side effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:3 - 30
Sex:All
Key Eligibility Criteria
Disqualifiers:Rhabdomyolysis, Glaucoma, Uncontrolled Diabetes, Others
Must Not Be Taking:CYP3A4 Inhibitors, CYP3A4 Inducers
24 Participants Needed
Selumetinib + Cabozantinib for Plexiform Neurofibroma
Birmingham, AlabamaBased on the clinical activity of both selumetinib and cabozantinib as monotherapies in clinical trials, the demonstrated activity of these agents in reduced doses in preclinical studies, and the non-overlapping toxicity profiles, the study will assess the tolerability and efficacy of selumetinib and cabozantinib in combination in participants with NF1 ≥16 years old with progressive and/or symptomatic PN in a phase 1/1b/2 clinical trial.
Trial Design Phase 1 This will be an open label, dose escalation phase. Dose level escalation will be determined by a rolling six design. In this design, up to 6 participants can be enrolled at a given dose level and then evaluated for dose limiting toxicity (DLT) within the DLT window. The DLT window is defined as 16 weeks in this study based on the long half-life of cabozantinib and the desire to have maximum confidence about long-term tolerability of the combination prior to proceeding to the next dose level.
Phase 1b Once the recommended phase 2 dose has been determined in phase 1, an expanded cohort of 12 participants will be enrolled in phase 1b portion of the study.
Phase 2 This will be an open label, single-arm phase using the recommended phase 2 dose.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:16+
Sex:All
30 Participants Needed
Chemotherapy + Radiation for Soft Tissue Sarcoma
Columbus, OhioThis trial is testing whether a new drug called pazopanib, when combined with chemotherapy and radiation, works better for patients with a specific type of soft tissue cancer. Pazopanib helps stop cancer cells from growing, while chemotherapy and radiation kill the cells. The goal is to see if this combination can improve treatment outcomes.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:2+
Sex:All
140 Participants Needed
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Frequently Asked Questions
How much do Plexiform Neurofibroma clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Plexiform Neurofibroma clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Plexiform Neurofibroma trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Plexiform Neurofibroma is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Plexiform Neurofibroma medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Plexiform Neurofibroma clinical trials ?
Most recently, we added Selumetinib + Cabozantinib for Plexiform Neurofibroma, AlgometRx Nociometer for Neurofibromatosis and HLX-1502 for Neurofibromatosis to the Power online platform.