Lymphoma
Conditions
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
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.
Interventions
BIOLOGICALautologous tumor cell vaccine
BIOLOGICALkeyhole limpet hemocyanin
BIOLOGICALsargramostim
PROCEDUREadjuvant therapy
Sponsors
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Humoral and Cellular Immune Response | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of Idiotype Vaccine | At each immunization and at study completion | To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting |
| Toxicity of Idiotype Vaccine | At each immunization and at study completion | To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting |
| Changes in Quantitative Bcl-2 | 1 year post transplant evaluation and then annually until disease progression | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Therapy vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
| Overall Study | Vaccine could not be produced | 1 |
Baseline characteristics
| Characteristic | Vaccine Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 46.7 years STANDARD_DEVIATION 10.68 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Number of Participants With Humoral and Cellular Immune Response
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
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
Population: NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.
Secondary
Changes in Quantitative Bcl-2
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.
Time frame: 1 year post transplant evaluation and then annually until disease progression
Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.
Secondary
Safety of Idiotype Vaccine
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time frame: At each immunization and at study completion
Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.
Secondary
Toxicity of Idiotype Vaccine
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time frame: At each immunization and at study completion
Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.