Clinical Trial: Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: St. Luke's Medical Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
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 mantle cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dexamethasone
 Drug: etoposide
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Cytarabine, Cisplatin, and Dexamethasone Followed By Cyclophosphamide, Etoposide, Total Body Irradiation, and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: March 1990

OBJECTIVES: I. Determine the toxicity and activity of cyclophosphamide, etoposide, total body irradiation, and autologous bone marrow transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma. II. Determine the feasibility of pretransplantation cytoreduction with a regimen of high-dose cytarabine, cisplatin, and dexamethasone in this patient population. III. Determine the feasibility of posttransplantation radiotherapy given to sites of residual disease (involved-field "boost" irradiation) in this patient population.

PROTOCOL OUTLINE: Patients are stratified by disease status (refractory vs relapsed). Autologous bone marrow is harvested before cytoreduction or involved field radiotherapy (IFRT). Patients with marrow involvement who achieve marrow complete response after cytoreduction undergo harvest of bone marrow before IFRT. Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours, cisplatin IV over 10 hours, and dexamethasone three times daily on days 1 and 2. At 3 weeks, a second course is administered if tumor reduction is at least 25% and in the absence of unacceptable toxicity. Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites, at least 90% of which can be treated with IFRT, undergo IFRT 5 days a week for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow. Within 10 days after completion of IFRT, patients receive etoposide IV over 26 hours beginning on day -7, cyclophosphamide IV over 2 hours on days -6 to -4, and total body irradiation twice daily on days -3 and -2 and once on day -1. Bone marrow is reinfused on day 0. Eligible patients with residual disease at 3 months after transplantation undergo involved field "boost" irradiation to sites of residual disease.

PROJECTED ACCRUAL: Approximately 50 patients (25 per stratum) will be accrued for this study.

Eligibility

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[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--

--Patient Characteristics--

  • Age: 16 and over
  • Performance status: CALGB 0-2; Karnofsky 70-100%
  • Life expectancy: More than 2 months
  • Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin less than 3 times normal; SGOT and SGPT less than 3 times normal; Alkaline phosphatase less than 3 times normal; Hepatitis B surface antigen negative
  • Renal: Creatinine normal; Creatinine clearance at least 60 mL/min
  • Cardiovascular: Cardiac ejection fraction normal by MUGA scan; No uncontrolled or severe cardiovascular disease, including the following: Myocardial infarction within the past 6 months Congestive heart failure; Symptomatic angina (despite optimal medical management); Life-threatening arrhythmia or hypertension
  • Pulmonary: Pulmonary function tests (DLCO and spirometry) greater than 60% predicted
  • Other: HIV negative; No serious organ dysfunction (unless caused by lymphoma); No active bacterial, viral, or fungal infection; No active peptic ulcer disease; No uncontrolled diabetes mellitus; No other malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer; No other serious medical or psychiatric illness that would preclude study; Not pregnant

Location Information


Wisconsin
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States

Study chairs or principal investigators

Robert F. Taylor,  Study Chair,  St. Luke's Medical Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000077128; STLMC-ABMR-9001; NCI-V91-0112
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002481
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005