NCT00109824

Brief Summary

Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's lymphoma. This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

May 3, 2005

Last Update Submit

June 3, 2013

Conditions

Recurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (4)

  • MEPD of single agent decitabine defined as the dose where an 80% decrease in DNMT1 protein level and a 100% increase in re-expression of the methylated target genes are noted in 5 of 6 patients, with DLT in less than or equal to 1 patient

    28 days

  • MTD of valproic acid in combination with the MEPD of decitabine defined as the dose level below that dose at which greater than or equal to 2 DLT are observed and that results in less than or equal to 1 DLT in 6 patients using CTCAE v3.0

    28 days

  • MEPD of valproic acid and decitabine defined as the dose where an 80% decrease in DNMT1 protein level and a 100% increase in re-expression of the methylated target genes are noted in 5 of 6 patients, with DLT in less than or equal to 1 patient

    28 days

  • Toxicities of single agent decitabine alone and in combination with valproic acid assessed using CTCAE v3.0

    Up to 3 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive decitabine IV over 1 hour on days 1-5 or 1-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Other: pharmacological studyOther: laboratory biomarker analysis

Arm II

EXPERIMENTAL

Patients receive decitabine as in stage 1 and valproic acid PO TID on days 5-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Drug: decitabineDrug: valproic acidOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

decitabineDRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC
Arm II
valproic acidDRUG

Given PO

Also known as: Alti-Valproic, Depakene, Novo-Valproic, VA
Arm II
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm IArm II
laboratory biomarker analysisOTHER

Correlative studies

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
  • Mantle cell lymphoma
  • Diffuse large cell lymphoma
  • Burkitt's lymphoma
  • Transformed NHL\* arising from a previously diagnosed low-grade lymphoma, including any of the following:
  • Follicular lymphoma
  • Small lymphocytic lymphoma
  • Chronic lymphocytic leukemia
  • Relapsed or refractory disease
  • Relapsed or refractory disease must have occurred during the most recent prior therapy
  • Has accessible tissue for biopsy OR evidence of ≥ 50% bone marrow involvement AND willing to undergo serial biopsy
  • Not eligible for OR refused curative stem cell transplantation
  • No active or untreated CNS lymphoma
  • Performance status - ECOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Interventions

DecitabineValproic Acid

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Kristie Blum

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

March 1, 2006

Primary Completion

March 1, 2009

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)