A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- etoposide
- Conditions
- Lymphoma
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TIME
Topotecan, Ifosfamide, Mesna and Etoposide
Intervention: etoposide
TIME
Topotecan, Ifosfamide, Mesna and Etoposide
Intervention: ifosfamide
TIME
Topotecan, Ifosfamide, Mesna and Etoposide
Intervention: topotecan hydrochloride
TIME
Topotecan, Ifosfamide, Mesna and Etoposide
Intervention: autologous bone marrow transplantation
TIME
Topotecan, Ifosfamide, Mesna and Etoposide
Intervention: Mesna
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 3 years
Progression-free survival as defined as the time from date of enrollment to the time of recurrence