Suspended

Phase I Study of Prolonged Low Dose Decitabine (5-Aza-Deoxycytidine, NSC #127716) in Patients With Biopsiable Advanced Cancers Refractory to Standard Therapy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

decitabine

+ pharmacological study
+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2004Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of single agent decitabine and its toxicity using this schedule in this population of patients with solid tumors or lymphomas. II. Definition of the dose at which tumor DNA demethylation is optimum. III. Definition of the dose at which peripheral blood mononuclear cell (PBMN) demethylation is optimal. IV. Definition of decitabine pharmacokinetics and correlation of plasma concentrations with hypomethylation effects. SECONDARY OBJECTIVES: I. Preliminary assessment of decitabine efficacy (objective response). OUTLINE: This is a dose-escalation study. Patients receive decitabine IV over 1 hour on days 1-5 or on days 1-5 and 8-12. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Official TitlePhase I Study of Prolonged Low Dose Decitabine (5-Aza-Deoxycytidine, NSC #127716) in Patients With Biopsiable Advanced Cancers Refractory to Standard Therapy 
NCT00089089
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: * Patients must have histologically confirmed malignancy (solid tumor or lymphoma) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Patients must have had \>= 1 prior chemotherapy regimen; there is no maximum allowable number of prior regimens, provided all other eligibility criteria are met * Patients must be \>= 6 weeks beyond treatment with a nitrosourea or mitomycin-C, \>= 4 weeks beyond other chemotherapy or radiotherapy, and must have recovered to =\< grade 1 toxicity for any treatment-limiting toxicity of prior therapy; (Exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy, provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field) * ECOG performance status =\< 2 (Karnofsky \>= 60%); (Exception: Patients with brain metastases must be ECOG performance status 0-1) * Leukocytes \>= 3,000/μL * Absolute neutrophil count \>= 1,500/μL * Platelets \>= 140,000/μL * Total bilirubin =\< 1.0 mg/dL * AST(SGOT)/ALT(SGPT) =\< 1.5 X institutional upper limit of normal * Creatinine (serum) =\< 1.5 mg/dL * PT within institutional guideline for biopsy procedure (=\< to 16 seconds) * The effects of decitabine on the developing human fetus are unknown; for this reason and because chemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document, including consent for the required tumor biopsy, blood and pharmacokinetics studies * Tumor accessible for repeat biopsy Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =\< grade 1 treatment-limiting toxicity levels for adverse events due to agents administered more than 4 weeks earlier; (Exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field) * Patients who have had surgery within 2 weeks prior to entering the study * Patients may not be receiving any other investigational agents * Patients with known brain metastases to whom any of the following apply: * Have not received prior cranial irradiation * Are requiring \> 8 mg dexamethasone per day (or equivalent other steroid) to maintain an ECOG performance status =\< 1 * Have had a seizure (focal or generalized) in the last 3 weeks * If steroids required to maintain an ECOG performance status =\< 1 have increased in the past 2 weeks * Take enzyme-inducing anti-convulsants * History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, potentially life threatening cardiac arrhythmia, systolic BP \< 90 mmHg or \> 160 mmHg, diastolic BP \< 50 mmHg or \> 110 mmHg, psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because decitabine is an antimetabolite with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine * Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, patients known to be HIV-positive and receiving anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with decitabine


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive decitabine IV over 1 hour on days 1-5 or on days 1-5 and 8-12. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Given IV

Correlative studies

Correlative studies
Study Objectives
Primary Objectives

Analysis of variance with Fisher's protected least significant difference to group dose levels that elicit consistent demethylation response will be used.

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
M D Anderson Cancer CenterHouston, United StatesSee the location

SuspendedOne Study Center
;