TEDDI-R for Central Nervous System Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:Secondary central nervous system lymphoma (sCNSL) is cancer that has spread to the central nervous system. Most drugs used to treat it do not cross the blood-brain barrier. This makes it hard to treat. Researchers hope that a new combination of drugs may be able to help.Objective:To find a better way to treat sCNSL.Eligibility:People ages 18 and older with sCNSLDesign:Participants will be screened with:* Medical history* Physical exam* Blood, urine, and heart tests* Eye exam* Tissue or tumor biopsy* Collection of cerebrospinal fluid* CT, PET, and MRI scans: Participants will like in a machine that takes pictures of the body.* Bone marrow aspirations or biopsies: A needle will be inserted into the participant s hipbone. The needle will remove a small amount of marrow.Participants will take the study drugs in 21-day cycles. They will take some drugs by mouth. They will take others through a catheter: A small tube will be inserted into a vein in the arm, neck, or chest. They may have drugs given through a catheter placed through the brain or injected into the spinal canal.Participants will have regular visits during the study. These will include repeats of the screening test. They may also provide a saliva sample or have a cheek swab.Participants will have up to 4 treatment cycles.Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for 3 years and then yearly....
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot take certain medications like strong CYP3A inhibitors or inducers within 7 days before starting the study. It's important to discuss your current medications with the study team to avoid any potential interactions.
Is the TEDDI-R treatment generally safe for humans?
The combination of temozolomide and Caelyx (pegylated liposomal doxorubicin) has been found to be generally well tolerated in patients with recurrent glioblastoma multiforme, with some experiencing manageable side effects like neutropenia (low white blood cell count), thrombocytopenia (low platelet count), rash, and nausea. Temozolomide alone has a good safety profile and is generally well tolerated in patients with brain metastases from solid tumors.12345
What makes the TEDDI-R drug unique for treating central nervous system lymphoma?
The TEDDI-R drug combines multiple agents, including Doxil, Etoposide, Ibrutinib, Rituximab, and Temozolomide, which together target cancer cells in different ways, potentially offering a more comprehensive approach than treatments using fewer drugs. This combination may be particularly effective for central nervous system lymphoma, where standard treatments are limited.678910
What data supports the effectiveness of the drug TEDDI-R for Central Nervous System Lymphoma?
Who Is on the Research Team?
Mark J Roschewski, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults aged 18+ with secondary central nervous system lymphoma (sCNSL) are eligible. They must have certain blood levels, organ function within specific ranges, and no recent chemotherapy or strong drug interactions. Women of childbearing age need a negative pregnancy test and must use effective birth control methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Ibrutinib Monotherapy Window
Participants receive ibrutinib monotherapy in combination with isavuconazole for 14 days to establish efficacy of ibrutinib
Treatment
Participants receive TEDDI-R or TEDD-R chemotherapy for up to 4 cycles based on response to the ibrutinib window
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Doxil
- Etoposide
- Ibrutinib
- Rituximab
- Temozolomide
Doxil is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor