5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 7, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at a new drug called Aza-TdC to see if it can help people with advanced solid tumors, which are types of cancer that form in organs and tissues. The main goal is to test how safe the drug is and to figure out the right dose that can be given to patients. To participate, you need to be at least 18 years old and have cancer that has gotten worse after standard treatments or for which there aren’t any effective options left. Participants will go through some health checks and will take the study drug by mouth in cycles over a period of three weeks.

During the trial, participants will take Aza-TdC once a day for 5 days, then have a break for 2 days, followed by a week without the drug. They will have regular check-ups, including blood tests and scans to monitor their tumors, and the treatment may continue as long as it is tolerated and the cancer is stable or improving. It's important to note that women who could become pregnant and men must use two forms of birth control during the study and for three months afterward. This trial is a way to explore new options for those with limited treatment choices, and both men and women of all backgrounds are welcome to apply.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy.
• • Age greater than or equal to 18 years of age.
• • ECOG performance status \< 2
• * Patients must have normal organ and marrow function as defined below:
• • absolute neutrophil count greater than or equal to 1,500/mcL
• • platelets greater than or equal to100,000/mcL
• • total bilirubin less than or equal to 1.5 X institutional upper limit of normal (\<=3 x upper limit of normal in the presence of documented Gilbert s syndrome)
• • AST(SGOT)/ALT(SGPT) less than or equal to 3 X institutional upper limit of normal
• • OR
• • AST(SGOT)/ALT(SGPT) less than or equal to 5 X institutional upper limit of normal for patients with liver metastases
• • creatinine less than or equal to 1.5X institutional upper limit of normal
• • OR
• • creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5X institutional normal
• • Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC.
• • Patients must have completed any chemotherapy, radiation therapy, or biologic therapy greater than or equal to 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be greater than or equal to 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment.
• • Ability to understand and the willingness to sign a written informed consent document.
• • Willingness to provide blood and urine samples for research purposes.
• • Ability to swallow pills/capsules.
• • Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry.
• • For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \& N lesions under visualization) and willingness to undergo tumor biopsies.
• EXCLUSION CRITERIA:
• • Patients who are receiving any other investigational agents.
• • Pregnant women and women who are breastfeeding are excluded from this study.
• • Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for greater than or equal to 1 month after treatment of the brain metastases.Patients should not be on anti-seizure medications. These patients may be enrolled at the discretion of the Principal Investigator.
• • Malabsorption syndrome or other conditions that would interfere with intestinal absorption.
• INCLUSION OF WOMEN AND MINORITIES:
• • Both men and women of all races and ethnic groups are eligible for this trial.