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

Sponsor:	University of Nebraska
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00006478

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 II

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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

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)

Detailed 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.

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

National Cancer Institute (NCI)

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 February 12, 2012