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A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma (NCT00003957)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma.
  • Biological: filgrastim
    • Biological: recombinant human stem cell factor
      • Drug: cyclophosphamide
        • Drug: cytarabine
          • Drug: etoposide
            • Drug: melphalan
              • Drug: mitoxantrone hydrochloride
                • Drug: paclitaxel
                  • Procedure: peripheral blood stem cell transplantation
                    Ages eligible for Study
                    18 Years and older
                    Genders eligible for Study
                    All
                    Accepts Healthy Volunteers
                    No
                    OBJECTIVES: I. Determine how many patients with chemotherapy sensitive relapsed non-Hodgkin's lymphoma receiving sequential high dose chemotherapy achieve a collection of a minimum 5 million CD34+ cells/kg in one large volume apheresis. II. Determine the feasibility and safety of this regimen in these patients. III. Determine disease free and overall survival of patients receiving this regimen.

                    OUTLINE: Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1. Filgrastim (G-CSF) and stem cell factor (SCF) are administered subcutaneously beginning on day 3 for approximately 7-14 days (until the completion of leukapheresis). Peripheral blood stem cells (PBSC) are collected over 3-5 days. Three weeks after leukapheresis is completed, patients receive cytarabine IV over 2 hours twice a day on days -6 to -3. Mitoxantrone IV is administered over 1 hour on day -6. CD34+ PBSC are reinfused on day 0. Four weeks later, patients receive etoposide IV over 11 hours on day -2 and melphalan IV over 30 minutes twice on day -1. CD34+ PBSC are reinfused on day 0. Concurrent G-CSF is administered subcutaneously and continues until blood counts recover. Patients are followed at 4 weeks, every 3 months for the first 2 years, and then every 6 months for the next 2 years.

                    PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

                    1 locations

                    United States (1)
                    • Fox Chase Cancer Center
                      Philadelphia, Pennsylvania, United States, 19111
                    Status:
                    completed
                    Type:
                    Interventional
                    Phase:
                    Start:
                    30 November, 1998
                    Updated:
                    15 April, 2013
                    Participants:
                    3
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