Overview

Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Biological therapy using growth factors may be effective in reducing side effects in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy, and peripheral stem cell transplantation. PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Etoposide
Ifosfamide
Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Non-Hodgkin's lymphoma
Hodgkin's disease Acute myelogenous leukemia Acute lymphoblastic leukemia Chronic
myelogenous leukemia Chronic lymphocytic leukemia Eligible for fractionated total body
irradiation plus high dose chemotherapy followed by autologous peripheral blood stem cell
support No prior entry into this study

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% SWOG 0 or 1
Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than
1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2
mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart
Association class III or IV heart disease Pulmonary: DLCO at least 60% predicted Other: No
other prior or concurrent malignancy No active infection or oral mucositis No diabetes
mellitus requiring insulin HIV negative No sensitivity to E. coli derived products Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone
marrow or peripheral blood stem cell transplantation No concurrent interleukin-11
Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine
therapy: Not specified Radiotherapy: See Disease Characteristics No prior extensive
radiotherapy that would preclude study irradiation Surgery: Not specified Other: At least
30 days since prior investigational study No other concurrent investigational agents No
concurrent prophylactic oral cryotherapy during study chemotherapy