NCT00005993

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Filgrastim and stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 and stem cell factor following peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma, Hodgkin's disease, or advanced breast cancer.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started May 1999

Longer than P75 for phase_1 breast-cancer

Status
terminated

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

May 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

June 21, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

6.2 years

First QC Date

July 5, 2000

Last Update Submit

November 27, 2017

Conditions

Breast CancerLymphoma

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent adult Hodgkin lymphomastage III grade 3 follicular lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent 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 lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell 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

aldesleukinDRUG
filgrastimDRUG
recombinant human stem cell factorDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Hodgkin's disease, non-Hodgkin's lymphoma, or advanced stage breast cancer Planned treatment is autologous peripheral blood stem cell transplantation No T-cell lymphomas Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Immunologic: No history of seasonal or recurrent asthma within the past 5 years No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection No anaphylactic/anaphylactoid type event manifested by disseminated urticaria, laryngeal edema, hypotension, and/or bronchospasm (e.g., food or insect venom) within the past 5 years Drug allergies manifested solely by rash allowed No history of angioedema or recurrent urticaria lasting longer than 14 days No history of hereditary or acquired angioedema No known allergy to E. coli derived products Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 week since prior hematopoietic growth factors Chemotherapy: Not specified Endocrine therapy: No concurrent steroids Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No concurrent beta adrenergic blocking agents No concurrent therapeutic antibiotics posttransplant No concurrent IV hyperalimentation or IV fluids posttransplant

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

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsLymphomaHodgkin DiseaseLymphoma, 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

aldesleukinFilgrastimStem Cell FactorPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative 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)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Linda J. Burns, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

June 21, 2004

Study Start

May 1, 1999

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 29, 2017

Record last verified: 2017-11