Overview
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Status:
Completed
Completed
Trial end date:
2002-12-01
2002-12-01
Target enrollment:
0
0
Participant gender:
All
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 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 peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Maryland
University of Maryland, BaltimoreCollaborator:
University of Maryland Greenebaum Cancer CenterTreatments:
Carmustine
Cisplatin
Cyclophosphamide
Dexamethasone
Etoposide
Melphalan
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed low grade follicular lymphoma, mantlecell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior
standard therapy Follicular lymphoma Must have poor prognosis disease defined as any of the
following: Any nodal or extranodal tumor mass with a diameter more than 7 cm Involvement of
at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms
Substantial splenic involvement no greater than 5 cm below left costal margin Serous
effusions (ascites, pleural or pericardial effusions) Orbital or epidural involvement
Ureteral compression Leukemia presentation (at least 500/microliter) Increased LDH level
Greater than 20% bone marrow involvement Mantle cell lymphoma No mantle zone morphology
Chronic lymphocytic leukemia Must have either anemia (hemoglobin less than 10 g/dL),
thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q,
elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly
No active CNS 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.
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available See
Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no
greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis
Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection
fraction at least 50% Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted Other: HIV
negative No active infection requiring intravenous antibiotics Not pregnant or nursing
Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: At
least 4 weeks since prior local radiotherapy Surgery: Not specified