NCT00258336

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

January 10, 2014

Status Verified

August 1, 2008

Enrollment Period

5.3 years

First QC Date

November 22, 2005

Last Update Submit

January 9, 2014

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Event-free survival by Kaplan-Meier

Secondary Outcomes (5)

  • Overall response rate (partial and complete response) at month 6 and any time

  • Time-to-progression by Kaplan-Meier

  • Duration of response

  • Immune response by cellular or humoral anti-idiotype response positive

  • Safety

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccineBIOLOGICAL
rituximabBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes: * Grade 1 or 2 follicular lymphoma * Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) * Measurable or evaluable disease after node biopsy * No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma * No CNS involvement with lymphoma PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2 times upper limit of normal * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * HIV negative * No other medical or psychiatric disease that would preclude study compliance * No other malignancy (active or treated) within the past 5 years PRIOR CONCURRENT THERAPY: Radiotherapy * Prior local radiotherapy allowed Other * No other prior anticancer therapy

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

Sponsors & Collaborators

Study Sites (1)

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

Rituximabsargramostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • John F. Bender, PharmD

    Favrille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2009

Last Updated

January 10, 2014

Record last verified: 2008-08

Locations

US(1)