Recruiting
Phase 2

Rituximab, Vaccine Therapy, GM-CSF

Sponsor:

Favrille

Code:

NCT00258336

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine

rituximab

sargramostim

Study Details

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.

Conditions

Lymphoma

Study ID

NCT00258336

Start date

Aug, 2004

Status verified date

Aug, 2008

Primary completion date

Nov, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine

rituximab

sargramostim

Primary outcome measure

  • Event-free survival by Kaplan-Meier [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Sarah Cannon Cancer Center at Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Clinical Trials Office - Sarah Cannon Cancer Center at Centenn

615-329-7274

More Information

Sponsor

Favrille

Last update posted

Jan 10, 2014

Last verified

Aug, 2008

Keywords

  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Favrille on 2014-01-10.