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Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma


OBJECTIVES:

- Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin
idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of
response rate (partial and complete) and event-free survival, in patients with indolent
B-cell non-Hodgkin's lymphoma.

- Determine the safety of this regimen in these patients.

- Evaluate development of an immune response in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

- Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4
weeks. Patients are evaluated for response at month 3. Patients with responding or
stable disease proceed to maintenance therapy. Patients with progressive disease are
removed from study.

- Maintenance therapy: Patients receive rituximab as in induction therapy in months 7,
13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once
daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with
continued response after completing 2 years of therapy may continue to receive FavId™
and GM-CSF once every 3 months in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival by Kaplan-Meier

Safety Issue:

No

Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Favrille

Authority:

Unspecified

Study ID:

CDR0000449719

NCT ID:

NCT00258336

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203