Bethesda, MDNCT03366116Now EnrollingIRB Ready

Neoplasms Clinical Trial in Bethesda, MD

Access cutting-edge neoplasms treatment through this phase 1 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Cancer Institute (NCI)

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related neoplasms treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Neoplasms Study in Bethesda

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 ...

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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 \>=18 years of age.
ECOG performance status \<= 2.
Patients must have normal organ and marrow function as defined below:
absolute neutrophil count \>= 1,500/mcL
platelets \>=100,000/mcL
total bilirubin \<=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) \<=3 X institutional upper limit of normal OR
AST(SGOT)/ALT(SGPT) \<=5 X institutional upper limit of normal for patients with liver metastases
creatinine \<=1.5X institutional upper limit of normal OR
creatinine clearance \>=60 mL/min/1.73 m\^2 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 or biologic therapy \>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. 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 primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
Evaluable or measurable disease outside the CNS
No metastases to brain stem, midbrain, pons, medulla, or cerebellum
No history of intracranial hemorrhage or spinal cord hemorrhage
No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1
Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1
Screening CNS radiographic study 2 weeks from completion of radiotherapy and \>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up.
Malabsorption syndrome or other conditions that would interfere with intestinal absorption.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT03366116) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neoplasms Treatment Options in Bethesda, MD

If you're searching for neoplasms treatment options in Bethesda, MD, this clinical trial (NCT03366116) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced neoplasms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neoplasms clinical trials near you to find additional studies recruiting in your area.

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