Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma

Favrille

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine; Biological: sargramostim

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00104819

FAV-WIRB-20041124

CWRU-100415

CWRU-FVID-2404

FAV-ID-09

CDR0000415573 (Registry Identifier)

CASE-2404

Details and patient eligibility

About

RATIONALE: Vaccines made from a person's cancer cells may make 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 and may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.

Full description

OBJECTIVES:

Primary

• Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06.

Secondary

• Determine the response rate and duration of response in patients treated with this regimen.
• Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
• Determine the time to progression in patients treated with this regimen.
• Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).

Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.

After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.

PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

  • Grade 1, 2, or 3

• Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06

• Meets 1 of the following criteria:

  • Received salvage therapy after completion of protocol FAV-ID-06

    • At least 4 weeks, but no more than 4 months, since prior salvage therapy

  • Did not receive salvage therapy after completion of protocol FAV-ID-06

    • At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06

• No history of CNS lymphoma OR meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No history of congestive heart failure

Pulmonary

• No history of compromised pulmonary function

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No active bacterial, viral, or fungal infection
• No psychiatric disorder
• No other serious nonmalignant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No prior allogeneic transplantation*
• No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks)

Chemotherapy

• No prior purine analogues* (e.g., fludarabine or cladribine)

Endocrine therapy

• No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from prior salvage therapy
• No prior or concurrent immunosuppressive therapy
• No prior investigational agents*
• No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study