NCT00086944

Brief Summary

This phase I/II trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

July 8, 2004

Last Update Submit

January 23, 2013

Conditions

Recurrent Adult Diffuse Large Cell LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Toxicity graded using the NCI CTCAE version 3.0

    Up to 3 years

  • Complete and partial response rate according to the International Workshop Criteria

    Up to 3 years

Secondary Outcomes (3)

  • Duration of response

    From the time measurement criteria are met for CR/CRu/PR until the first date that PD is objectively documented, assessed up to 3 years

  • Overall survival

    From the first day of therapy to the date of death, assessed up to 3 years

  • Time to progression

    From the first day of treatment until the date PD or death is first reported, assessed up to 3 years

Study Arms (1)

Treatment (genase, combination chemotherapy)

EXPERIMENTAL

See detailed description.

Biological: oblimersen sodiumBiological: rituximabDrug: ifosfamideDrug: carboplatinDrug: etoposideBiological: filgrastimBiological: pegfilgrastimOther: laboratory biomarker analysis

Interventions

oblimersen sodiumBIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Treatment (genase, combination chemotherapy)
rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (genase, combination chemotherapy)
ifosfamideDRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP
Treatment (genase, combination chemotherapy)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (genase, combination chemotherapy)
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Treatment (genase, combination chemotherapy)
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Treatment (genase, combination chemotherapy)
pegfilgrastimBIOLOGICAL

Given SC

Also known as: Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF
Treatment (genase, combination chemotherapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (genase, combination chemotherapy)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma
  • Any 1 one of the following histological subtypes for phase I:
  • Grade 3 follicular center lymphoma
  • Diffuse large B-cell lymphoma
  • Transformed follicular lymphoma
  • Mantle cell lymphoma
  • Primary mediastinal B-cell lymphoma
  • Any 1 of the following histological subtypes for phase II:
  • Diffuse large B-cell lymphoma
  • Transformed follicular lymphoma
  • Primary mediastinal B-cell lymphoma
  • Measurable disease
  • At least 1 bidimensionally measurable lesion ≥ 10 mm in longest diameter by CT scan, MRI, x-ray, or clinical exam
  • Relapsed disease after 1, and only 1, prior anthracycline-based chemotherapy regimen
  • No known brain metastases
  • +35 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-Cell

Interventions

oblimersenRituximabIfosfamideindolepropanol phosphateCarboplatinEtoposideFilgrastimGranulocyte Colony-Stimulating Factorpegfilgrastim

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Sonali Smith

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

July 1, 2006

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)