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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002481
First received: November 1, 1999
Last updated: December 17, 2013
Last verified: May 2001
  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 Intervention Phase
Lymphoma
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Procedure: autologous bone marrow transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1990
Detailed Description:

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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven or unequivocal radiologic evidence of non-Hodgkin's lymphoma that has relapsed or is refractory after first-line chemotherapy Unequivocal radiologic evidence of relapse defined as the presence of enlarged (at least 2 cm diameter) lymph nodes by CT scan or lymphangiogram Biopsy of accessible lymph nodes to confirm relapse encouraged Low-, intermediate-, or high-grade disease Normal bilateral bone marrow biopsy at time of bone marrow collection required (cellularity at least 20% and no histologic evidence of tumor) History of marrow involvement allowed if present marrow is histologically normal No disease progression in a previously irradiated site 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: 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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior nitrosourea allowed if cumulative dose no more than 600 mg/m2 Prior bleomycin allowed if cumulative dose no more than 300 units/m2 Prior doxorubicin allowed if cumulative dose no more than 450 mg/m2 No prior high-dose etoposide (more than 1,800 mg/m2) No prior high-dose cyclophosphamide (more than 100 mg/kg) No chemotherapy within 4 weeks (no melphalan, nitrosourea, or mitomycin within 6 weeks) prior to bone marrow collection No prior salvage therapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to liver or lung Prior other radiotherapy allowed if doses do not exceed the following limits: 1,400 cGy to the mediastinum 1,400 cGy to the whole abdomen 4,000 cGy to the CNS Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002481

Locations
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
St. Luke's Medical Center
Investigators
Study Chair: Robert F. Taylor, MD St. Luke's Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002481     History of Changes
Other Study ID Numbers: CDR0000077128, STLMC-ABMR-9001, NCI-V91-0112
Study First Received: November 1, 1999
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Cisplatin
Cyclophosphamide
Cytarabine
Dexamethasone
Etoposide
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 22, 2014