Will DNA methylation inhibitors work in solid tumors? A review of the clinical experience with azacitidine and decitabine in solid tumors.
Lisa A Cowan, Sundeep Talwar, Allen S Yang
https://pubmed.ncbi.nlm.nih.gov/22122748Actively Recruiting
Phase 1
Age: 18Years - 120Years
All Genders
ID03366116
Phase I Trial of 5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients With Advanced Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new drug called Aza-TdC in people with advanced solid tumors whose cancer has worsened after standard treatments or for whom no effective treatment exists. The research aims to find out the safety, tolerability, and the best dose of this drug to give to patients. Aza-TdC works by targeting gene silencing mechanisms involved in cancer growth, potentially reactivating genes that slow tumor growth. Participants will take Aza-TdC by mouth in cycles of 21 days. In each cycle, they take the drug once daily for 5 days in week 1 and 5 days in week 2, followed by a week without the drug. The first cycle includes repeated screening tests, while later cycles involve blood and pregnancy tests, and tumor scans every 6 weeks. Treatment continues as long as the drug is tolerated and the cancer does not worsen. During the study, participants undergo medical history reviews, blood and urine tests, heart activity tests, and tumor scans. Researchers monitor safety, drug levels in the body, gene activity in tumor cells, and DNA changes in tumor tissue. The main goal is to determine the safety and best dose of Aza-TdC, while also studying its effects on tumors and gene expression. Participants stay in the study until treatment is no longer appropriate or cancer progresses.
CONDITIONS
Brief Title
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
Who Can Participate
Age: 18Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed solid tumors that have progressed on standard therapy or lack effective therapy
- Age 18 years or older
- ECOG performance status of 2 or less
- Normal organ and bone marrow function as defined by specific blood counts and liver and kidney tests
- Agreement to use two forms of contraception during and for 3 months after study participation if of child-bearing potential
- Completion of prior chemotherapy or biologic therapy at least 4 weeks before enrollment
- Ability to understand and sign informed consent
- Willingness to provide blood and urine samples for research
- Ability to swallow pills or capsules
- Left ventricular ejection fraction greater than 45% or within institutional normal limits
- For expansion cohort, tumor must be suitable for biopsy and willingness to undergo biopsies
You will not qualify if you...
- Receiving other investigational agents
- Pregnant or breastfeeding women
- Clinically significant illnesses that may interfere with study participation, including uncontrolled infections, immune deficiencies, HIV needing certain therapy, hepatitis B or C, uncontrolled diabetes or hypertension, heart failure, recent heart attack, arrhythmia, or psychiatric/social conditions limiting compliance
- Known primary central nervous system malignancy or symptomatic CNS metastases, except certain controlled or asymptomatic cases
- Malabsorption syndrome or conditions interfering with intestinal absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive oral Aza-TdC once daily for 5 days a week for 2 weeks, followed by one week off, repeated in 21-day cycles.
Daily dosing for 5 days per week over 2 weeks, then 1 week off per cycle
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
D
DTC Referral Coordinators
J
James H Doroshow, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Novel DNA methyltransferase-1 (DNMT1) depleting anticancer nucleosides, 4'-thio-2'-deoxycytidine and 5-aza-4'-thio-2'-deoxycytidine.
Jaideep V Thottassery, Vijaya Sambandam, Paula W Allan...
https://pubmed.ncbi.nlm.nih.gov/24908436Synthesis and anti-cancer activity of some novel 5-azacytosine nucleosides.
Kamal N Tiwari, Loredana Cappellacci, John A Montgomery...
https://pubmed.ncbi.nlm.nih.gov/14714764