Clinical trial NCT00002510: Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Official title: HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Keywords: Waldenstrom macroglobulinemia
recurrent small lymphocytic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
First posted: 2004-08-23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and radiation therapy and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

Detailed description: OBJECTIVES: I. Evaluate the overall and progression-free survival of patients with selected poor-prognosis non-Hodgkin's lymphomas treated with high-dose etoposide and total-body irradiation followed by rescue with peripheral blood stem cells. II. Determine the toxicity of this regimen. III. Evaluate the short-term and long-term engraftment characteristics of patients treated on this regimen.

OUTLINE: Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are treated on Regimen B. Regimen A: Single-Agent Chemotherapy/Stem Cell Mobilization with Urothelial Protection and Growth Factor Therapy. Cyclophosphamide, CTX, NSC-26271; with Mesna, NSC-113891; and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Sequential Radiotherapy, Single-Agent Chemotherapy, and Stem Cell Rescue. Total-body irradiation, TBI (equipment not specified); Etoposide, VP-16, NSC-141540; and Peripheral Blood Stem Cells, PBSC.

PROJECTED ACCRUAL: 20 patients will be studied.

Eligibility criteria: DISEASE CHARACTERISTICS: Pathologically confirmed non-Hodgkin's lymphomas of the following histologic subtypes: Small lymphocytic Follicular small cleaved cell Follicular mixed cell Follicular large cell (relapsed) Disease in first, second, or third partial remission (25% shrinkage in cross-sectional area of measurable disease) or first, second, or subsequent relapse required Transformed non-Hodgkin's lymphoma eligible, i.e., low-grade lymphoma subsequently transformed to intermediate- or high-grade lymphoma No lymphosarcoma cell leukemia

PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: Karnofsky 80-100% Hematopoietic: WBC at least 5,000/mm3 (polys at least 2,000/mm3) Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times normal Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: LVEF at least 50% Pulmonary: FVC greater than 1.5 liters FEV1 greater than 1.2 liters MVV greater than 50 liters DLCO greater than 12 mL/min pO2 greater than 70 mm Hg on room air Other: No other serious psychiatric, neurologic, or medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Less than 3,500 cGy prior irradiation to the mediastinum, lungs, or spinal cord Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Thomas R. Klumpp, MD
role: STUDY_CHAIR
References: