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A Phase II Trial of Risk-Adapted High-Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients with Relapsed and Primary Refractory Hodgkin's Lymphoma
[Protocol 04-047]
- Full Title :
- RISK-ADAPTED HIGH DOSE CHEMORADIOTHERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION FOR PATIENTS WITH RELAPSED AND PRIMARY REFRACTORY HODGKIN'S LYMPHOMA
- Purpose :
Hodgkin's disease that has not responded to treatment or that has come back after treatment can rarely be cured with standard treatment. In this study, investigators are evaluating two forms of second-line treatment to see if they can improve the cure rate of patients with Hodgkin's disease that was not cured with the first treatment.
The first form of second-line treatment is a combination of the drugs ifosfamide, carboplatin, and etoposide (ICE), which has been used since 1993 and is well tolerated by patients. After this treatment, patients will undergo positron emission tomography (PET) scanning. Those whose PET scans are negative will have high-dose chemotherapy and radiation therapy plus an autologous stem cell transplant (in which some stem cells are removed before treatment and then returned to the patient after therapy is completed so the immune system can be "rebuilt").
Patients whose PET scans indicate that Hodgkin's disease is still present after ICE treatment will receive a combination of the drugs gemcitabine, vinorelbine (also called navelbine), and Doxil -- so-called "GND therapy." Those whose Hodgkin's disease improves after GND therapy will then receive high-dose chemotherapy and radiation therapy plus an autologous stem cell transplant.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of Hodgkin's lymphoma that has recurred despite or has failed to respond to therapy. Patients' disease must be measurable using PET scanning.
- Patients' initial therapy must have included doxorubicin or a nitrogen mustard-containing drug. Those who have already been treated with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine may not participate.
- Patients must be between the ages of 18 and 72.
For more information and to see if you are eligible for this study, please contact Dr. Craig Moskowitz at 212-639-2696.
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