Ifosfamide, Teniposide, and Paclitaxel in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

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

Sponsors

Lead Sponsor: Northwestern University

Collaborator: National Cancer Institute (NCI)

Source Northwestern University
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.

Detailed Description

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.

Overall Status Completed
Start Date 1999-02-01
Completion Date 2002-10-01
Primary Completion Date 2002-10-01
Phase Phase 1/Phase 2
Study Type Interventional
Condition
Intervention

Intervention Type: Drug

Intervention Name: ifosfamide

Intervention Type: Drug

Intervention Name: paclitaxel

Intervention Type: Drug

Intervention Name: teniposide

Intervention Type: Procedure

Intervention Name: peripheral blood stem cell transplantation

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Leo I. Gordon, MD Study Chair Robert H. Lurie Cancer Center
Location
Facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Location Countries

United States

Verification Date

2012-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary Purpose: Treatment

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