NCT00004197

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim 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 chemotherapy. PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive 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 Jun 1999

Geographic Reach
1 country

2 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

June 25, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2003

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 25, 2004

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

January 21, 2000

Last Update Submit

September 3, 2023

Conditions

Lymphoma

Keywords

stage I grade 3 follicular lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage III grade 3 follicular lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage I mantle cell lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell 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 lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Interventions

keyhole limpet hemocyaninBIOLOGICAL
sargramostimBIOLOGICAL
tumor cell-based vaccine therapyBIOLOGICAL
cyclophosphamideDRUG
Also known as: Cytoxan
doxorubicin hydrochlorideDRUG
Also known as: Lipodox, Lipodox 50, and Doxil
mitoxantrone hydrochlorideDRUG
Also known as: Novantrone
prednisoneDRUG
Also known as: Prednisone Intensol, Deltasone, Rayos
vincristine sulfateDRUG
Also known as: Kyocristine, Vincrisul, Onkovin

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma
  • Diffuse mixed cell
  • Diffuse large cell
  • Immunoblastic Follicular large cell with more than 50% large cells
  • Mantle cell
  • Non-age adjusted International Prognostic Index 2-4
  • Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy
  • Must have adequate circulating lymphoma cells
  • Over 18 years old
  • Karnofsky 80-100%
  • WBC greater than 2,500/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin at least 10 g/dL
  • Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal
  • Creatinine less than 2.0 mg/dL
  • +3 more criteria

You may not qualify if:

  • No CNS metastasis
  • No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study
  • No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing/negative pregnancy test
  • No prior biologic therapy for lymphoma
  • No prior cytotoxic chemotherapy for lymphoma
  • No prior steroids for lymphoma
  • No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent
  • No prior radiotherapy for lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticLymphoma, Mantle-Cell

Interventions

keyhole-limpet hemocyaninsargramostimCyclophosphamideDoxorubicinliposomal doxorubicinMitoxantronePrednisoneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAnthraquinonesAnthronesAnthracenesQuinonesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

June 25, 2004

Study Start

June 25, 1999

Primary Completion

January 1, 2002

Study Completion

November 20, 2003

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

US(2)