Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma
- Determine the toxicities associated with the combination of ifosfamide, teniposide, and
weekly paclitaxel in patients with relapsed non-Hodgkin's lymphoma.
- Evaluate response rate and time to disease progression in these patients treated with
OUTLINE: This is a dose escalation study of teniposide. Patients are stratified according to
whether they proceed to stem cell transplant or not.
Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks, teniposide IV over
2 hours on day 1 every 3 weeks, and paclitaxel IV over 1 hour weekly. Patients who are not
candidates for stem cell transplant continue treatment for 120 days in the absence of
disease progression or unacceptable toxicity. Patients proceeding to stem cell transplant
continue treatment for 36 days. Peripheral blood stem cells (PBSC) may be harvested at this
time if autologous transplant is planned. Transplant patients may then continue with
chemotherapy or proceed to autologous or allogeneic PBSC transplant.
Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3
of 5 patients experience dose limiting toxicities.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Leo I. Gordon, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|