Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

filgrastim

+ cyclophosphamide

+ etoposide

BiologicalDrugProcedureRadiation
Who is being recruted

Blood Protein Disorders+24

+ Cardiovascular Diseases

+ Chronic Disease

From 16 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: April 1992
See protocol details

Summary

Principal SponsorTemple University
Last updated: October 1, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00002510
Principal SponsorTemple University
Last updated: October 1, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesLeukemia, B-CellHemostatic DisordersDisease AttributesNeoplasms, Plasma CellLymphomaLymphoma, FollicularWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-Cell

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Temple University Cancer Center

Philadelphia, United StatesOpen Temple University Cancer Center in Google Maps
CompletedOne Study Center