NCT00040950

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. Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2002

Typical duration for phase_1 lymphoma

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

March 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 19, 2013

Status Verified

July 1, 2003

First QC Date

July 8, 2002

Last Update Submit

December 18, 2013

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

rituximabBIOLOGICAL
agatolimod sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL) * CD20 positive by immunohistochemistry or flow cytometry * Relapsed or refractory disease * Bidimensionally measurable disease * Sole site of measurable disease within a previously irradiated field allowed provided there was disease progression at that site * No pre-existing ascites or pleural effusions * No known CNS involvement by NHL PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Neutrophil count at least 1,000/mm3 * Platelet count at least 50,000/mm3 Hepatic: * Bilirubin less than 2 mg/dL * Transaminase less than 2 times upper limit of normal * No hepatitis B or C Renal: * Creatinine less than 2 mg/dL Cardiovascular: * No significant cardiovascular disease * No New York Heart Association class III congestive heart failure * No myocardial infarction within the past 6 months * No unstable angina * No uncontrolled atrial or ventricular cardiac arrhythmias Pulmonary: * No concurrent significant pulmonary disease Other: * HIV negative * No acute infection requiring antibiotics * No fever over 38.2 degrees C within the past 3 days * No other malignancy within the past 5 years except basal cell or noninvasive squamous cell skin cancer or carcinoma in situ of the cervix * No pre-existing autoimmune disease or antibody-mediated disease, including: * Systemic lupus erythematosus * Rheumatoid arthritis * Multiple sclerosis * Sjogren's syndrome * Autoimmune thrombocytopenia * Controlled thyroid disease allowed * Concurrent autoantibodies without clinical autoimmune disease allowed * No history of allergic reactions attributed to compounds of similar composition to study drugs * No other medical history, including laboratory results, that would preclude study * No suspected or confirmed poor compliance or mental instability that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior allogeneic transplantation * More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF) or epoetin alfa) * More than 30 days since prior immunotherapy * More than 90 days since prior monoclonal antibodies as monotherapy for patients who were unresponsive to treatment (30 days for patients who responded to treatment and subsequently relapsed) * No other concurrent biological agents * No concurrent hematopoietic growth factors (e.g., G-CSF or epoetin alfa) Chemotherapy: * More than 30 days since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * More than 30 days since prior systemic corticosteroids * No concurrent systemic corticosteroids Radiotherapy: * See Disease Characteristics * More than 30 days since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * Recovered from prior therapy * At least 6 months since prior coronary angioplasty * More than 30 days since prior immunosuppressants * More than 30 days since prior participation in an investigational drug study * No concurrent immunosuppressants * No concurrent anticoagulants except aspirin at doses no greater than 325 mg/day * No other concurrent anticancer therapy * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Leonard JP, Link BK, Emmanouilides C, Gregory SA, Weisdorf D, Andrey J, Hainsworth J, Sparano JA, Tsai DE, Horning S, Krieg AM, Weiner GJ. Phase I trial of toll-like receptor 9 agonist PF-3512676 with and following rituximab in patients with recurrent indolent and aggressive non Hodgkin's lymphoma. Clin Cancer Res. 2007 Oct 15;13(20):6168-74. doi: 10.1158/1078-0432.CCR-07-0815.

    PMID: 17947483RESULT

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Christos E. Emmanouilides, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Study Completion

October 1, 2007

Last Updated

December 19, 2013

Record last verified: 2003-07

Locations

US(1)