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Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
Not Recruiting
Trial ID: NCT00510471
Purpose
The treatment being investigated is a patient- and tumor-specific therapy known as a
personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a
person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together
with the personalized active immunotherapy because it may increase the immune system's
response and, therefore, aid in the effect of the personalized active immunotherapy.
This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma
and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile
have been seen to date in these studies.
Official Title
A Phase 2 Multi-Center, 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 Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)
Eligibility
Inclusion Criteria:
1. Written informed consent
2. Previously untreated follicular NHL
3. Stage III or IV disease requiring treatment
4. Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide,
vincristine, and prednisone either with or without doxorubicin)
5. Able to provide tumor sample adequate for Id-KLH manufacture
6. ≥ 18 years of age
7. At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Intervention(s):
drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Susie Bawn
6507254968