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Hematopoietic/Lymphoid CancerPhase 1NCT00089089

Decitabine in Treating Patients With Advanced Refractory Solid Tumors or Lymphomas

A Phase 1 study testing decitabine, pharmacological study and laboratory biomarker analysis in people with Hematopoietic/Lymphoid Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of decitabine in treating patients with metastatic or unresectable refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
decitabine, pharmacological study and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Sep 2004to Mar 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

This phase I trial is studying the side effects and best dose of decitabine in treating patients with metastatic or unresectable refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
decitabine, pharmacological study, laboratory biomarker analysis
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • decitabineDrug

    Also called 5-aza-dCyd, 5AZA, DAC

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00089089
Study groupRoleWhat they receive
Treatment (decitabine)ExperimentalPatients 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.
Receives: Drug: decitabine; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase II dose will be defined as the lowest dose at or below the maximum tolerated dose (MTD; based on dose limiting toxicity) consistent with a plateau reduction in DNA methylation in target tumor tissue

    Measured: 4 weeks

  2. Tumor demethylation response, measured by percent change in DNA methylation using the ALU assay

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

    Measured: Baseline to day 12 course 1

  3. Adequacy of peripheral blood mononuclear cell DNA methylation as a surrogate for tumor DNA methylation, measured by effect of dose on reduction in DNA methylation in peripheral blood mononuclear cells

    Measured: Day 12 course 1

  4. Pharmacokinetic parameters, including Cmax, Tmax, AUC, t ½ α, t ½ β, Vd, and clearance

    Measured: Days 1 and 5 of course 1

Secondary outcomes (1)

  1. Response using RECIST

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089089
Sponsor's protocol ID
NCI-2012-03096
Other IDs
2004-0040, U01CA062461
Status last verified
Jan 2013
First submitted
4 Aug 2004
Last updated
7 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing decitabine, pharmacological study and laboratory biomarker analysis in people with Hematopoietic/Lymphoid Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II dose will be defined as the lowest dose at or below the maximum tolerated dose (MTD; based on dose limiting toxicity) consistent with a plateau reduction in DNA methylation in target tumor tissue (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.

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