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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

Phase 2
16 Years
Open (Enrolling)

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Trial Information

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

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

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

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert F. Taylor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center


United States: Federal Government

Study ID:




Start Date:

March 1990

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin



St. Luke's Medical Center Milwaukee, Wisconsin  53215