Aza-TdC for Solid Tumors
Trial Summary
What is the purpose of this trial?
Background: Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the instruction book for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were turned off. Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC. Objective: To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans. Eligibility: People ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists Design: Participants will be screened with: Medical history Blood and urine tests Scans to measure their tumors Test to measure the electrical activity of the heart Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long. Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment. For cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks. The cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better. Sponsoring Institute: National Cancer Institute
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have completed any chemotherapy, radiation, or biologic therapy at least 4 weeks before starting the study. You can continue intravenous bisphosphonate treatment if you have bone metastases or hypercalcemia.
What data supports the effectiveness of the drug Aza-TdC for solid tumors?
What safety data exists for Aza-TdC in humans?
Aza-TdC, also known as 5-azacytidine or 5-aza-2'-deoxycytidine, has been associated with significant side effects in humans, including blood-related issues (myelosuppression) and digestive problems. In some studies, serious complications like infections (sepsis) and bleeding in the brain (cerebral hemorrhage) have been reported, leading to fatalities.36789
What makes the drug Aza-TdC unique for treating solid tumors?
Aza-TdC is unique because it is an orally bioavailable drug that selectively depletes DNMT1, an enzyme involved in DNA methylation, with lower toxicity compared to similar drugs like decitabine. This means it can potentially be used at effective doses for longer durations with fewer side effects.810111213
Research Team
James H Doroshow, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults over 18 with advanced solid tumors that have worsened after standard treatment or for which no effective therapy exists. They must be in relatively good health, able to swallow pills, and willing to use two forms of contraception. Excluded are pregnant or breastfeeding women, those with significant illnesses like uncontrolled infections or heart problems, known HIV requiring specific therapy, Hepatitis B/C, brain metastases unless stable and not on anti-seizure meds.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Aza-TdC orally once a day for 5 days a week for 2 weeks, with one week off, in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue treatment as long as the drug is tolerated and the cancer is stable or improving
Treatment Details
Interventions
- Aza-TdC
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor