Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
This study has been terminated.
(Genitope suspend development of MyVax in light of the decision made by the Food and Drug Administration (FDA) March 6, 2008)
Sponsor:
University of Nebraska
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00006478
First received: November 6, 2000
Last updated: March 1, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: autologous tumor cell vaccine Biological: keyhole limpet hemocyanin Biological: sargramostim Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma |
Resource links provided by NLM:
Further study details as provided by University of Nebraska:
Primary Outcome Measures:
- Number of Participants With Humoral and Cellular Immune Response [ Time Frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression ] [ Designated as safety issue: No ]evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
Secondary Outcome Measures:
- Safety [ Time Frame: At each immunization and at study completion ] [ Designated as safety issue: Yes ]To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
- Toxicity [ Time Frame: At each immunization and at study completion ] [ Designated as safety issue: Yes ]To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
- Changes in Quantitative Bcl-2 [ Time Frame: 1 year post transplant evaluation and then annually until disease progression ] [ Designated as safety issue: No ]To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.
| Enrollment: | 19 |
| Study Start Date: | September 2000 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006478
Locations
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
Sponsors and Collaborators
University of Nebraska
Investigators
| Study Chair: | Julie M. Vose, MD | University of Nebraska |
More Information
No publications provided
| Responsible Party: | Julie M. Vose, UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| ClinicalTrials.gov Identifier: | NCT00006478 History of Changes |
| Other Study ID Numbers: | 260-00, P30CA036727, UNMC-260-00, GENITOPE-IND-8294 |
| Study First Received: | November 6, 2000 |
| Results First Received: | October 19, 2010 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Nebraska:
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Keyhole-limpet hemocyanin Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013