Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Leo I. Gordon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 98H2
NCT ID:
NCT00004916
Start Date:
February 1999
Completion Date:
October 2002
Related Keywords:
- Lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
