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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States
Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant
Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and
Time frame: After vaccination
Safety and toxicity of idiotype vaccine post-transplant setting
Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time frame: Post-transplant vaccination
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