Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma
ifosfamide
+ paclitaxel
+ teniposide
DNA Virus Infections+17
+ Hemic and Lymphatic Diseases
+ Herpesviridae Infections
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: 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 this regimen. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma No lymphoblastic or small cleaved lymphoma Progressive disease following doxorubicin based chemotherapy No more than 2 prior treatment regimens Measurable or evaluable disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No significant cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled second malignancy No other medical problems that would preclude therapy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Prior stem cell transplant allowed Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps