Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Registration Number
- NCT00510471
- Lead Sponsor
- Genitope Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Written informed consent
- Previously untreated follicular NHL
- Stage III or IV disease requiring treatment
- Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
- Able to provide tumor sample adequate for Id-KLH manufacture
- ≥ 18 years of age
- At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Keck School of Medicine of University Southern California
🇺🇸Los Angeles, California, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Weill Medical College of Cornell University, NY Presbyterian Hospital
🇺🇸New York, New York, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Providence Portland Cancer Center
🇺🇸Portland, Oregon, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States