Lymphoma
Conditions
Brief summary
This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging.
Detailed description
This trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on trials 0197-99-FB and 0196-99-FB. These follicular NHL participants then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants are then followed annually until progression or death with standard staging. Immune response testing continues annually on participants who continue to have a response post transplant.
Interventions
BIOLOGICALId-KLH
Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
Sponsors
Genitope Corporation
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
* histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma * original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine * failed to achieve PR or CR with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a CR or good PR following transplantation -\>/= 19 years * signed informed consent * non-pregnant, non-lactating
Exclusion criteria
* serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant | After vaccination | Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and toxicity of idiotype vaccine post-transplant setting | Post-transplant vaccination | Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting |
Countries
United States
Outcome results
None listed