Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
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.
Drug: topotecan hydrochloride
Procedure: autologous bone marrow transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk Lymphoma|
- Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Progression-free survival as defined as the time from date of enrollment to the time of recurrence
|Study Start Date:||February 2000|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Topotecan, Ifosfamide, Mesna and Etoposide
Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3
Other Names:Drug: ifosfamide
Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6
Other Name: Ifex(R)Drug: topotecan hydrochloride
Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6
Other Name: topotecanProcedure: autologous bone marrow transplantation Drug: Mesna
Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6
Other Name: Mesnex(R)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006373
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Steven C. Goldstein, MD||H. Lee Moffitt Cancer Center and Research Institute|