Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the efficacy of mobilization using filgrastim (G-CSF) with or without standard-dose ifosfamide, carboplatin, and etoposide (ICE), conditioning using ifosfamide and etoposide plus total body irradiation or high-dose ICE, and autologous peripheral blood stem cell (PBSC) transplantation as salvage therapy in patients with refractory, recurrent, or poor prognosis non-Hodgkin's lymphoma.
* Determine the efficacy of reinduction comprising ICE followed by autologous PBSC transplantation in these patients.
* Determine the ability of standard-dose ICE combined with hematopoi...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• * One of the following diagnoses:
• • Histologically proven recurrent non-Hodgkin's lymphoma
• • Previously in complete remission (CR)
• * Refractory or recurrent intermediate-grade lymphoma (IGL) or high-grade immunoblastic lymphoma (IBL) meeting 1 of the following conditions:
• • In partial remission (PR) or CR to and currently enrolled on the MSKCC standard dose salvage regimen with ifosfamide, carboplatin, and etoposide (ICE)
• • In PR or CR after 1-2 other salvage chemotherapy regimens (e.g., 3 courses of dexamethasone, high-dose cytarabine, and cisplatin (DHAP); 2 courses of cyclophosphamide, mechlorethamine, vincristine, procarbazine, and prednisone (C-MOPP))
• • No prior ifosfamide
• • Low-grade lymphoma
• • In second or greater remission or chemosensitive relapse
• • No HLA identical sibling donor available
• • IGL or IBL
• • In first CR
• • Poor prognosis, defined by age-adjusted international index of 3 or 4 based on lactic dehydrogenase, number of extranodal sites, stage, and performance status
• • Adequate bone marrow cellularity
• • No lymphoblastic or small noncleaved cell lymphoma
• • Ineligible for total body irradiation (TBI) phase of study if prior radiotherapy dose precludes the use of TBI NOTE: 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:
• • Physiologic 18 to 65
• Performance status:
• • Not specified
• Hematopoietic:
• • Not specified
• Hepatic:
• • Bilirubin no greater than 2.0 mg/dL (if no history of Gilbert's disease)
• • No chronic active or persistent hepatitis
• * Hepatitis B positivity allowed provided that the following conditions are met:
• • Bilirubin same as above\*
• • SGPT no greater than 500 IU/L\*
• • Alkaline phosphatase no greater than 2 times normal\* NOTE: \* In the absence of liver involvement by lymphoma
• Renal:
• • Creatinine no greater than 1.5 mg/dL OR
• • Creatinine clearance at least 60 mL/min
• • No history of chronic renal insufficiency
• Cardiovascular:
• • LVEF at least 50% by echocardiogram or MUGA scan
• • No myocardial infarction within the past 6 months
• • No unstable angina
• • No arrhythmia other than chronic atrial fibrillation
• Pulmonary:
• • DLCO at least 50% predicted (corrected for hemoglobin and alveolar ventilation)
• Other:
• • HIV negative
• • No uncontrolled infection
• • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
• • Not pregnant or nursing
• • Negative pregnancy test
• • Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• • Biologic therapy
• • Not specified
• • Chemotherapy
• • See Disease Characteristics
• • Endocrine therapy
• • Not specified
• • Radiotherapy
• • See Disease Characteristics
• • Surgery
• • Not specified

Trial Officials