Overview
Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2003-06-01
2003-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy plus radiation therapy followed by peripheral stem cell transplantation in patients with refractory or recurrent non-Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterTreatments:
Carboplatin
Etoposide
Ifosfamide
Sargramostim
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