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.

Condition	Treatment or Intervention	Phase
recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: peripheral blood stem cell transplantation  Drug: bone marrow ablation with stem cell support  Drug: ifosfamide  Drug: paclitaxel  Drug: teniposide	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine the toxicities associated with the combination of ifosfamide, teniposide, and weekly paclitaxel in patients with relapsed non-Hodgkin's lymphoma. II. Evaluate response rate and time to disease progression in these patients treated with this regimen.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

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.

--Prior/Concurrent Therapy--

Biologic therapy: Prior stem cell transplant allowed

Chemotherapy: See Disease Characteristics

Endocrine therapy: Not specified

Radiotherapy: Not specified

Surgery: Not specified

--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

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

Study chairs or principal investigators

Leo I. Gordon,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067597; NU-98H2; NCI-G00-1711
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004916
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08