Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma

Stopped early · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00510471

Run by

Genitope Corporation

Starts

2007-05-01

Last updated by the study team

2008-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Keck School of Medicine of University Southern California — Los Angeles, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Weill Medical College of Cornell University, NY Presbyterian Hospital — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
• Providence Portland Cancer Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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