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 |
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.
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.
- 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
Omaha, Nebraska 68198
402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
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