Lymphoma
Conditions
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Brief summary
RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine. * Determine the durability of these immunologic responses in these patients. * Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses. * Determine the safety and tolerability of this vaccine in these patients. OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses. Immunologic responses are serially monitored along with disease status. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Interventions
BIOLOGICALHodgkin's antigens-GM-CSF-expressing cell vaccine
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of classic Hodgkin's lymphoma * Must have completed first-line therapy without evidence of disease progression PATIENT CHARACTERISTICS: * HIV negative PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 6 months since prior chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | After administration of last vaccine at 9 weeks |
| Immunologic Response | 9 months |
| Durability of Immunologic Response | 2 years |
| Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cell Vaccine After Initial Therapy for Hodgkin Lymphoma Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
Hodgkin's antigens-GM-CSF-expressing cell vaccine
adjuvant therapy | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Durability of Immunologic Response
Time frame: 2 years
Population: The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.
Primary
Immunologic Response
Time frame: 9 months
Population: The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.
Primary
Safety and Tolerability
Time frame: After administration of last vaccine at 9 weeks
Population: The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.
Primary
Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
Time frame: 2 years
Population: The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.