High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma
filgrastim
+ CHOP regimen
+ carboplatin
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: June 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Evaluate the response to a 8 week induction chemotherapy program consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with mantle cell lymphoma. II. Evaluate the efficacy of ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and filgrastim (G-CSF) for peripheral blood stem cell (PBSC) mobilization in this patient population. III. Evaluate the safety and efficacy of ICE followed by total body irradiation and high dose cyclophosphamide and etoposide in this patient population. IV. Assess the contamination of PBSCs by lymphoma cells following mobilization by chemotherapy and G-CSF in this patient population. OUTLINE: Patients receive induction chemotherapy with cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, oral prednisone daily on days 2-6, and filgrastim (G-CSF) subcutaneously daily on days 6-10. Treatment is repeated every 14 days for up to 4 courses. Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2, etoposide IV daily on days 1-3, and G-CSF subcutaneously on days 5-12 for course 1, and on day 5 for course 2 and continuing through peripheral blood stem cell (PBSC) collection. Treatment is repeated every 14 days for 2 courses. Following PBSC collection, patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6, -5, and -4 and cyclophosphamide IV daily on days -3 and -2. PBSCs are infused on day 0. Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. PROJECTED ACCRUAL: Approximately 14-24 patients will be accrued for this study within two years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 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
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV mantle cell lymphoma (diffuse, nodular, mantle zone, or blastic variants) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic active or persistent hepatitis Bilirubin less than 2 mg/dL (unless history of Gilbert's disease) Renal: No history of chronic renal insufficiency Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: At least 6 months since myocardial infarction No unstable angina No cardiac arrhythmias other than chronic atrial fibrillation LVEF at least 50% Pulmonary: DLCO at least 50% Other: No medical illness that would preclude study treatment No uncontrolled infection No history of malignancy, other than curatively treated basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Not HIV positive PRIOR CONCURRENT THERAPY: No prior therapy
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps