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Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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 UniversityChicago, Illinois  60611