Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

University of Nebraska

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Biological: sargramostim; Biological: autologous tumor cell vaccine; Biological: keyhole limpet hemocyanin; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006478

0260-00-FB

GENITOPE-IND-8294

37-7109-2007-001 (Other Grant/Funding Number)

Details and patient eligibility

About

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

Full description

OBJECTIVES:

• Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
• Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
• Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.

OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Enrollment: 19 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 19 years of age

• Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy

• Minimal disease state at day 100 to 6 months post-transplantatio

  • Lymph nodes smaller than 2 centimeters (cm)
  • Less than 20% bone marrow involvement with lymphoma
  • Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease

• Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy

  o Must have adequate circulating lymphoma cells

• Karnofsky greater than 70%

• Absolute neutrophil count greater than 1,000/mm^3 (No restrictions if study vaccine administered at 6 months after transplantation)

• CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation)

• Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)

• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement)

• Creatinine no greater than 2.0 mg/dL

• Fertile patients must use effective contraception during and for 6 months after study participation

Exclusion criteria

• Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
• Not pregnant or nursing/negative pregnancy test

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

Experimental group

Description:

Phase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.

Treatment:

Biological: keyhole limpet hemocyanin

Biological: autologous tumor cell vaccine

Procedure: adjuvant therapy

Biological: sargramostim