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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:9/5/2018
Start Date:September 2000
End Date:April 2008

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Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

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.

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.

DISEASE CHARACTERISTICS:

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

- Previously received no more than 2 high-dose chemotherapies before hematopoietic stem
cell transplantation

- Minimal disease state at day 100 to 6 months post-transplantation

- 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

- Must have adequate circulating lymphoma cells

PATIENT CHARACTERISTICS:

Age:

- Over 19

Performance status:

- Karnofsky greater than 70%

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count greater than 1,000/mm^3*

- CD4+ count greater than 200/microliter* NOTE: *No restrictions if study vaccine
administered at 6 months after transplantation

Hepatic:

- 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)

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified
We found this trial at
1
site
985950 Nebraska Medical Center
Omaha, Nebraska 68198
402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
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mi
from
Omaha, NE
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