NCT00070083

Brief Summary

RATIONALE: 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 cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen when given together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in treating patients with stage II, stage III, or stage IV large B-cell lymphoma

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
Last Updated

April 7, 2009

Status Verified

June 1, 2005

First QC Date

October 3, 2003

Last Update Submit

April 4, 2009

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Interventions

oblimersen sodiumBIOLOGICAL
rituximabBIOLOGICAL
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
prednisoneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed\* CD20+ diffuse large B-cell lymphoma, including any of the following stages: * Extensive stage II (not radio-encompassable within a single involved field or not a candidate for brief chemotherapy and radiotherapy) * Bulky stage II (any single mass greater than 10 cm) * Stage III * Stage IV NOTE: \*Confirmed by tissue biopsy * Previously untreated disease * Measurable disease * At least 2 cm by imaging studies * Circulating lymphoma cells no greater than 5,000/mm\^3 * No history of other lymphoproliferative disorder * No history of indolent lymphoma * No T-cell lymphoma * No CNS involvement * No post-transplantation lymphoproliferative disorder PATIENT CHARACTERISTICS: Age * 19 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 (unless due to bone marrow involvement with lymphoma) * Platelet count at least 100,000/mm\^3 (unless due to splenomegaly or bone marrow involvement with lymphoma) Hepatic * Bilirubin no greater than 3 mg/dL (unless due to lymphoma) * No known hepatitis B virus Renal * Creatinine no greater than 2 mg/dL (unless due to lymphoma) Cardiovascular * No cardiac contraindication to doxorubicin therapy (e.g., abnormal contractility on echocardiography) * History of cardiac disease allowed provided ejection fraction is normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate venous access * HIV negative * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, localized basal cell or squamous cell skin cancer, or curatively treated carcinoma in situ of the cervix * No neurological contraindication to vincristine (e.g., peripheral neuropathy) * No active systemic infection * No medical condition that would compromise study treatment, add toxicity, or impair assessment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior systemic chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy * Prior radiotherapy for localized basal cell or squamous cell skin cancer used with curative intent allowed Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

oblimersenRituximabCyclophosphamideDoxorubicinPrednisoneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Richard J. Klasa, MD

    British Columbia Cancer Agency

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

July 1, 2003

Last Updated

April 7, 2009

Record last verified: 2005-06

Locations

US(1)CA(3)