Overview

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

Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
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