A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk Lymphoma
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival as defined as the time from date of enrollment to the time of recurrence
Steven C. Goldstein, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|