Clinical trial NCT00006478: Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
Official title: Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Number of Participants With Humoral and Cellular Immune Response
timeFrame: 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
Secondary outcomes:
measure: Safety of Idiotype Vaccine
timeFrame: At each immunization and at study completion
measure: Toxicity of Idiotype Vaccine
timeFrame: At each immunization and at study completion
measure: Changes in Quantitative Bcl-2
timeFrame: 1 year post transplant evaluation and then annually until disease progression
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Julie M Vose, MD
role: STUDY_CHAIR
References: