E3404 - Synopsis for Patients
ECOG trial number
ECOG E3404
Protocol title
Phase II Study of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone With or Without Response-Adapted Therapy Comprising Rituximab, Ifosfamide, Carboplatin, and Etoposide in Patients With Bulky Stage II or Stage III or IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma.
Principal investigator
Dr. William Solomon, MD
Contacts
Please call the study coordinator:
- Susanne Fryd at 718- 270-7366
Description
Patient enrolled in ECOG E3404 will have a PET scan before treatment and standard staging tests. Staging tests are done to establish the extent of lymphoma and involves blood tests, a full body CAT scan, and bone marrow biopsy. Patients will then receive 3 cycles of standard R-CHOP chemotherapy (rituximab,cyclophosphamide, vincristine, doxorubicin and prednisone). This will be followed by a mid treatment PET scan. While this is undergoing review, patients will receive their 4th cycle of R-CHOP.
- If the PET scan is negative, patients will complete an additional two cycles of R-CHOP (standard therapy).
- If the PET scan is positive, patients will be designated to the experimental arm and complete 4 cycles of R-ICE chemotherapy (rituximab, ifosfamide, mesna, carboplatin and etoposide).
Purpose of study
Lymphomas are cancers of the lymph nodes. Lymph nodes are normal “glands” that often become swollen during infections. Lymph nodes contain two types of cells that serve this function. These cells are called B-cells and T cells. Lymphomas arise when either B-cells or T cells grow in an unregulated manner.
There are two types of lymphomas Hodgkins and non Hodgkins. This distinction is important, because the treatment and prognosis is different. A biopsy, or sample of tissue is required to make the diagnosis.
Our study is specifically targeting patients with aggressive non-Hodgkin’s lymphoma involving B cells that are growing in a diffuse pattern. Other B cell lymphomas do not grow diffusely and are not classified as aggressive.
In 2007 there were an estimated 63,190 new cases of non-Hodgkins lymphoma in the United States. Approximately 30% of these cases are classified as diffuse large B-cell lymphomas, which are aggressive lymphomas if left untreated, progress rapidly, resulting in death within months. With standard treatment, called “chemotherapy”, just over 50% of patients will be free from their cancer in 3 years.
A PET scan, is a special imaging technique that is a very sensitive measure of lymphoma activity. Lymphoma cells like to use the sugar glucose to grow. A PET scan uses radiolabeled glucose and can be used to monitor lymphomas before, during and after chemotherapy. It has been demonstrated that PET scanning after a few cycles of chemotherapy is a strong indicator of tumor response and ultimate outcome.
The purpose of this study is to use a PET scan to identify patients that are not likely to be cured of there lymphoma using standard chemotherapy. Instead, we would like to offer these patients an experimental therapy with hopes to improve their prognosis. The “experimental” therapy is a well established chemotherapy that is widely used for patients who do not respond to standard chemotherapy. Our goal is to use PET scanning in order to adjust treatment as early as possible to ideally “cure” more lymphomas.
You can be in the study if you are
- Age 18-70
- Diffuse large B cell lymphoma
- No prior chemotherapy
- HIV negative
To find out if you could be included in this study, please call
Susanne Fryd at 718-270-7366.
We will be happy to go over the eligibility criteria with you in details.
Non-Hodgkin's Lymphoma - ECOG E3404 - Patient Version
Updated: May 22, 2008
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