Overview
Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia
Status:
Completed
Completed
Trial end date:
2003-07-01
2003-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma or acute lymphoblastic leukemia.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Northwestern UniversityCollaborator:
National Cancer Institute (NCI)Treatments:
Cyclophosphamide
Etoposide
Criteria
DISEASE CHARACTERISTICS: Histologically proven high grade lymphoma (including smallnoncleaved) by lymph node biopsy OR acute lymphoblastic leukemia (ALL) by bone marrow
aspiration and biopsy Lymphoblastic lymphoma: First remission allowed if elevated LDH or
stage IV disease Early relapse allowed Must have CT of abdomen, pelvis, and chest obtained
within 4-6 weeks prior to enrollment Measurable disease not required First remission
transplantation is encouraged if poor prognostic indicators were present at diagnosis and
the objective parameter of measure is long term disease free survival ALL: Patients with
inaspirable bone marrow aspirate smears eligible if diagnosis confirmed by bone marrow core
biopsy Any complete remission allowed All patients in relapse should have attempted
reinduction of remission Patients in early relapse (defined as no greater than 20%
lymphoblasts in bone marrow) eligible if bone marrow harvested while in remission (less
than 5% blasts) Must be eligible for total body irradiation Negative CSF cytology within
4-6 weeks of enrollment No active CNS lymphoma or leukemia 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 age 65 and under for autologous peripheral blood
stem cell transplantation If age 55 and under, priority should be given to finding an
allogeneic donor Performance status: ECOG 0 or 1 Life expectancy: Not specified
Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL
SGOT or SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular:
Cardiac ejection fraction at least 40% by MUGA scan or clearance by a cardiologist No
myocardial infarction within the past 6 months No active angina pectoris Pulmonary: FEV1
and DLCO at least 50% predicted Other: No active serious psychiatric or medical illness
that would preclude administration of high dose chemotherapy HIV negative Not pregnant
Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
No prior radiotherapy greater than 25 Gy to the craniospinal axis Surgery: See Disease
Characteristics