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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Northwestern University

ClinicalTrials.gov Identifier:

NCT00004916

First received: March 7, 2000

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2000

Last Updated Date

May 31, 2012

Start Date ^ICMJE

February 1999

Primary Completion Date

October 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Drug: ifosfamide
Drug: paclitaxel
Drug: teniposide
Procedure: peripheral blood stem cell transplantation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

October 2002

Primary Completion Date

October 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00004916

Other Study ID Numbers ^ICMJE

NU 98H2, NU-98H2, NCI-G00-1711

Has Data Monitoring Committee

Yes

Responsible Party

Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Leo I. Gordon, MD

Robert H. Lurie Cancer Center

Information Provided By

Northwestern University

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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