Overview

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2001-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fox Chase Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Cytarabine
Etoposide
Melphalan
Mitoxantrone
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed follicular or diffuse large cell, diffuse
mixed, or immunoblastic non-Hodgkin's lymphoma (working formulation D, F, G, or H) First
relapse from a complete response or complete response unconfirmed after a front line
chemotherapy regimen (e.g., CHOP-like regimen) Second relapse from partial response after
2-4 courses of second line standard dose chemotherapy (e.g., MINE, EPOCH, or
platinum-containing regimens) No more than 1 salvage treatment regimen No CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Transaminases no greater than 2 times upper limit of normal
Bilirubin no greater than 2 mg/dL (unless due to biopsy proven lymphoma) No chronic viral
hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60
mL/min No overt renal insufficiency Cardiovascular: LVEF at least 45% No congestive heart
failure (New York Heart Association class III or IV) No myocardial infarction within past 6
months No uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg) No
unstable angina No coronary angioplasty within past 6 months No uncontrolled atrial or
ventricular cardiac arrhythmias Pulmonary: DLCO and FEV1 at least 45% of predicted No
severe pulmonary disease No seasonal or recurrent asthma within past 10 years No asthmatic
symptoms (e.g., wheezing) related to current respiratory tract infection No concurrent
symptoms of bronchoconstriction No anaphylactic/anaphylactoid-type event manifested by
disseminated urticaria, laryngeal edema, and/or bronchospasm Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception HIV negative No
prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal
cell or squamous cell skin cancer No severe medical or psychiatric illness (including
severe depression) No active peptic ulcer disease No poorly controlled diabetes No allergy
to insect vemons No active history of angioedema or recurrent urticaria (an isolated
episode of urticaria is allowed) No active infection No fever greater than 38.2 degrees C
(except fevers due to B symptoms) No allergy to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior hematopoietic
growth factors Chemotherapy: See Disease Characteristics At least 4 weeks since prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to
relapsed sites of vital organs (except as part of initial treatment) At least 4 weeks since
prior palliative radiotherapy to bulky nodes Surgery: At least 2 weeks since prior major
surgery Other: No other concurrent investigational drugs No concurrent beta adrenergic
blocking agents