Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma
Recruitment status was: Recruiting
RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.
|Brain and Central Nervous System Tumors Lymphoma Lymphoproliferative Disorder Small Intestine Cancer||Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim Drug: methotrexate Drug: thiotepa Radiation: radiation therapy||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With CNS Lymphoma|
- Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
- Safety and tolerability
- Progression-free survival (PFS)
- Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
- Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival
- Kinetics of humoral immune response development
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- To determine the proportion of patients with CNS lymphoma who develop anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) humoral immune responses in the serum and/or CSF following patient-specific immunotherapy comprising recombinant tumor-derived immunoglobulin Id-KLH conjugate vaccine and sargramostim (GM-CSF).
- To assess the safety and tolerability of this regimen in these patients.
- To evaluate the progression-free survival (PFS) of patients treated with this regimen.
- To determine the time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine.
- To assess the correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival.
- To evaluate the kinetics of humoral immune response development in patients treated with this regimen.
- Pre-immunotherapy: Patients submit a tumor sample for manufacturing of the idiotype (Id)-keyhole limpet hemocyanin (KLH) conjugate vaccine and undergo placement of an Ommaya reservoir. Patients then receive induction therapy comprising methotrexate IV once every 2 weeks until a maximum radiographic response is achieved, as assessed by MRI of the brain. Patients then receive methotrexate IV once a month for 6 months. Patients with leptomeningeal or CSF involvement also receive intraventricular thiotepa twice a week until the CSF is clear on three evaluations and then once a week until the CSF is clear on four evaluations. Patients under 55 years of age also undergo whole brain radiotherapy (or craniospinal radiotherapy when extensive leptomeningeal disease is present). Patients who achieve a stable response to induction therapy proceed to immunotherapy.
- Immunotherapy: Patients receive recombinant tumor-derived immunoglobulin Id-KLH conjugate vaccine subcutaneously (SC) on day 1 of weeks 0, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76. Patients also receive sargramostim (GM-CSF) SC on days 1-4 of the same weeks as the Id-KLH conjugate vaccine.
After completion of therapy, patients are followed periodically for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621036
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Principal Investigator:||Elizabeth Maher, MD, PhD||Simmons Cancer Center|