Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00002982
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Assess the efficacy and toxic effects of carmustine/etoposide/melphalan (ICE) chemotherapy followed by peripheral blood progenitor cell transplantation in patients with refractory or relapsed intermediate grade non-Hodgkin's lymphoma.
* Assess the ability of the ICE chemotherapy regimen, in conjunction with filgrastim, to mobilize peripheral blood stem cells.
OUTLINE: This is a descriptive pilot study.
Patients receive 3 cycles of induction chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). Each cycle is given at least 14 days apart. Patients receive etoposide IV on days 1 through 3. Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV over 24 hours on day 2.
During cycles 1 and 2, patients receive filgrastim (G-CSF) SC every 6 hours beginning on day 1 and continuing until the desired absolute neutrophil count (ANC) is attained.
Patients receive at least 24 hours of rest before PBPC infusion on day 0.
Following cycle 3, G-CSF is given SC beginning on day 6 and continuing until completion of PBPC collection. However, bone marrow will be harvested if an insufficient number of stem cells are collected after 5 leukaphereses.
Patients with residual disease limited to 2 sites receive radiation therapy twice a day within 2 weeks prior to high dose BEAM chemotherapy with carmustine, etoposide, cytarabine, and melphalan.
Patients receive carmustine IV on day -7. Etoposide and cytarabine are given IV every 12 hours on days -6 through -3. Melphalan is given IV on day -2.
G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC is attained. If ANC is attenuated on day 21, patients undergo a repeat bone marrow biopsy and receive filgrastim SC.
Patients are followed for 2 years posttransplant, then for 3 to 5 years at 4 month intervals and every 6 months following the fifth posttransplant.
PROJECTED ACCRUAL: This study will accrue 30 patients for the duration of 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-related toxicity
- Secondary Outcome Measures
Name Time Method Efficacy in terms of 2-year disease-free survival
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States