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Stem Cell Therapy + Chemotherapy for Brain Tumor
Study Summary
This trial is testing the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells given with irinotecan hydrochloride for high-grade gliomas. The hope is that the genetically modified neural stem cells will make the tumor more sensitive to the irinotecan hydrochloride, which may stop the growth of the tumor cells.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358Trial Design
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Who is running the clinical trial?
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- You are currently taking herbal medications.You have received treatment with neural stem cells in the past.You are able to perform daily activities and tasks with at least 70% efficiency.You have a serious illness that is not well controlled.You currently have an infection that needs antibiotics.You have experienced allergic reactions to drugs that are similar to irinotecan.You are allergic or sensitive to any of the medications that will be given to you during the study.You need to have surgery to remove a brain tumor or have a brain biopsy to determine if the tumor is growing or if it's a side effect of radiation therapy or chemotherapy.According to the neurosurgeon's assessment, there is no expected direct connection between the surgical cavity and the fluid-filled spaces in the brain.You have any other type of cancer that is currently active.
- Group 1: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Would I qualify to participate in this research program?
"Currently, 18 individuals with glioma aged between 18 and 69 are eligible to apply for this clinical trial. Candidates must fulfill the following conditions: comprehension of written informed consent documents, having a Karnofsky performance status >= 70%, willingness to adhere to study/follow-up procedures, life expectancy > 3 months, histologically confirmed diagnosis of grade II - IV glioma (including but not limited to glioblastoma and anaplastic oligoastrocytoma), imaging evidence indicating recurrence or progression after previous radiation therapy + temozolomide treatment; if enrolling at dose level two or higher there"
In what conditions are Pharmacological Studies most frequently prescribed?
"Pharmacological Study is a common intervention for treating malignant neoplasms of the pancreas. Additionally, this medication may aid in managing metastasis, gastric cancer, and rhabdomyosarcoma cases."
To what extent can participating in a Pharmacological Study jeopardize patient safety?
"Our enterprise has assigned Pharmacological Study a score of 1 due to the limited data available surrounding its safety and efficacy as this is an initial-phase trial."
What are the intended outcomes of this experiment?
"The aim of this 28 day clinical trial is to determine the frequency of adverse reactions as evaluated by the NCI CTCAE v4.0 while also monitoring other secondary objectives, such as patient response based on MRI results, NSC immunogenicity after first and repeat exposures, and ultimately measuring NSC persistence through descriptive statistics and graphical methods."
Does this experiment have any available spaces for volunteers?
"Unfortunately, according to clinicaltrials.gov this trial is no longer searching for patients. Despite that being the case, it was initially posted on March 7th 2016 and last updated on June 7th 2022. Fortunately, there are still 1,885 other studies actively recruiting right now."
How many individuals are being enrolled in this experimental study?
"Unfortunately, this trial is not currently open to new participants. It was first announced on March 7th 2016 and last updated on June 7th 2022. Nonetheless, if you are seeking out other medical studies, there are 1622 trials actively searching for glioma patients and 263 Pharmacological Studies welcoming volunteers."
Could you please provide an overview of any past experimentation regarding Pharmacological Study?
"At present, 263 clinical trials related to Pharmacological Study are in progress with 53 of them being in their third phase. The most numerous concentration of these studies is located in Melbourne, Victoria but there are 8629 locations across the world running research for this particular study."
Is this trial open to elderly participants?
"Patients of legal age (over 18) and under 69 are eligible for inclusion in this study."
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