Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Procedure: autologous bone marrow transplantation
- Registration Number
- NCT00006373
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow 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 followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of intensive high dose chemotherapy consisting of topotecan, ifosfamide, and etoposide followed by autologous bone marrow or peripheral blood stem cell transplantation in terms of response rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's lymphoma.
* Determine the pharmacokinetic profile of high dose topotecan and etoposide in these patients.
* Determine the pharmacodynamics and toxicity of this regimen in these patients.
* Determine the role of either an up or down regulation of DNA topoisomerase I or II amount and/or activity in terms of clinical response and toxicity in patients treated with this regimen.
OUTLINE: Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2 hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously over 24 hours on days -5 to -3. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0.
Patients are followed at 3, 6, and 12 months, annually until disease relapse, and then every 6 months until death.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TIME topotecan hydrochloride Topotecan, Ifosfamide, Mesna and Etoposide TIME autologous bone marrow transplantation Topotecan, Ifosfamide, Mesna and Etoposide TIME Mesna Topotecan, Ifosfamide, Mesna and Etoposide TIME etoposide Topotecan, Ifosfamide, Mesna and Etoposide TIME ifosfamide Topotecan, Ifosfamide, Mesna and Etoposide
- Primary Outcome Measures
Name Time Method Progression-free survival 3 years Progression-free survival as defined as the time from date of enrollment to the time of recurrence
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States