NCT00012207

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy 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

Enrollment
12

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

3 active sites

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

September 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

First QC Date

March 3, 2001

Last Update Submit

August 20, 2010

Conditions

LeukemiaLymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr

Secondary Outcomes (4)

  • Duration of in vivo persistence of adoptively transferred CD20-specific CD8+ T cell clones by flow cytometry and quantitative polymerase chain reaction (qPCR) during each infusion, weekly for 4 weeks, and then monthly for a year

  • Trafficking of CD8+ CD20-specific T cell clones to lymph nodes by Gamma camera imaging during each infusion, weekly for 4 weeks, and then monthly for a year

  • Development of host anti-scFvFc:zeta (and anti-NeoR) immune responses by ELISA and chromium release assays during each infusion, weekly for 4 weeks, and then monthly for a year

  • Tumor responses to cyclophosphamide, vincristine, and prednisone (CVP) and to cytotoxic T-lymphocyte (CTL) infusions by Cheson criteria during each infusion, weekly for 4 weeks, and then monthly for a year

Interventions

aldesleukinBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
cyclophosphamideDRUG
prednisoneDRUG
vincristine sulfateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma * Indolent B-cell lymphomas including any of the following subtypes: * Follicular lymphoma (grade I, II, or III) * Small lymphocytic lymphoma or chronic lymphocytic leukemia * Marginal zone lymphoma (splenic, nodal, and extra-nodal) * Lymphoplasmacytoid lymphoma * Ineligible for or unwilling to participate in other FHCRC/UWMC protocols * Serological evidence of prior exposure to Epstein-Barr virus * Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node biopsy, and nuclear medicine imaging * Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to \< 5 cm in diameter or circulating B lymphocyte counts to \< 5,000/mm\^3 * No pulmonary involvement * No CNS involvement PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * At least 90 days Hematopoietic: * Not specified Hepatic: * No active hepatitis B infection Renal: * Not specified Other: * No HIV positivity * Not pregnant or nursing * Fertile patients must use effective contraception * No history of hypersensitivity reactions to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 months since prior rituximab, tositumomab, or ibritumomab * No prior allogeneic stem cell transplantation * No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products) Chemotherapy: * At least 2 years since prior fludarabine or cladribine * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 4 weeks since prior immunosuppressive therapy and recovered * No concurrent pentoxifylline * 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 (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Till BG, Jensen MC, Wang J, Chen EY, Wood BL, Greisman HA, Qian X, James SE, Raubitschek A, Forman SJ, Gopal AK, Pagel JM, Lindgren CG, Greenberg PD, Riddell SR, Press OW. Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells. Blood. 2008 Sep 15;112(6):2261-71. doi: 10.1182/blood-2007-12-128843. Epub 2008 May 28.

    PMID: 18509084RESULT

MeSH Terms

Conditions

LeukemiaLymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

aldesleukinCyclophosphamidePrednisoneVincristineChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Oliver W. Press, MD, PhD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2001

First Posted

January 27, 2003

Study Start

September 1, 2000

Study Completion

July 1, 2010

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(3)