Stem Cell Therapy + Chemotherapy for Brain Tumor
Trial Summary
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting treatment. You must stop using specific drugs, such as certain anticonvulsants, CYP3A4 inhibitors, UGT1A1 inhibitors, and herbal medications, at least 2 weeks before the trial begins. It's best to discuss your current medications with the trial team to see if any need to be paused.
What data supports the effectiveness of the treatment Stem Cell Therapy + Chemotherapy for Brain Tumor?
Research shows that using neural stem cells to deliver enzymes that activate the drug irinotecan (CPT-11) can effectively target brain tumors, increasing the drug's potency and reducing tumor growth in preclinical models. This approach has shown promise in treating various cancers, including brain tumors, by enhancing the conversion of irinotecan to its active form, SN-38, directly at the tumor site.12345
Is the combination of stem cell therapy and chemotherapy safe for treating brain tumors?
Research shows that using neural stem cells to deliver chemotherapy drugs like irinotecan (CPT-11) to brain tumors can help target the tumor more effectively and reduce side effects. This approach has been tested in animal models and shows promise for being safe, but more studies are needed to confirm its safety in humans.12345
How is the stem cell therapy with irinotecan different from other brain tumor treatments?
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells when given together with irinotecan hydrochloride in treating patients with high-grade gliomas that have come back. Placing genetically modified neural stem cells into brain tumor cells may make the tumor more sensitive to irinotecan hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.
Research Team
Jana L Portnow
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients with recurrent high-grade brain tumors like glioblastoma or astrocytoma, who have already tried standard treatments. They must be in good enough health to understand the study and undergo surgery, with a life expectancy of at least 3 months. Participants can't join if they've had neural stem cell therapy before, are on certain drugs that affect the treatment, or have infections like HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive carboxylesterase-expressing allogeneic neural stem cells intracranially and irinotecan hydrochloride intravenously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 30 days, 3 and 6 months, and then annually for a minimum of 15 years.
Treatment Details
Interventions
- Carboxylesterase-expressing Allogeneic Neural Stem Cells
- Irinotecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator