Overview
Combination Chemotherapy Followed By Autologous Stem Cell Transplant, and White Blood Cell Infusions in Treating Patients With Non-Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2013-03-01
2013-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells, that have been treated in the laboratory with antibodies, may make the transplant work better. Giving combination chemotherapy followed by an autologous stem cell transplant, and white blood cell infusions may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of white blood cell infusions when given together with combination chemotherapy, and autologous stem cell transplant in treating patients with non-Hodgkin's lymphoma that has relapsed, is refractory, or is in remission.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Barbara Ann Karmanos Cancer InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Carmustine
Cytarabine
Etoposide
Etoposide phosphate
Melphalan
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed CD20+ non-Hodgkin's lymphoma
- Disease is refractory, relapsed, or in remission
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin > 8 g/dL
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- SGOT or SGPT ≤ 2.5 times normal
- No history of severe hepatic dysfunction
Renal
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
- No uncompensated major adrenal dysfunction
- BUN < 1.5 times normal
Cardiovascular
- No severe cardiac dysfunction
- No major heart disease
- LVEF ≥ 50% by MUGA
- No uncontrolled hypertension
- No congenital or acquired heart disease or cardiac arrhythmias unless cardiac consult
and evaluation are done
Pulmonary
- DLCO ≥ 50% of normal
- No symptomatic obstructive or restrictive disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infections
- HIV negative
- No significant skin breakdown from tumor or other diseases
- Dental evaluation and teeth cleaning with no potential sources of infection required
- No uncompensated major thyroid dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior stem cell transplantation
Chemotherapy
- No prior total doxorubicin or daunorubicin dose ≥ 450 mg/m^2 unless endomyocardial
biopsy shows < grade 2 drug effect AND ejection fraction ≥ 50% by gated blood pool
scan
Endocrine therapy
- No concurrent hormonal therapy except steroids for adrenal failure, septic shock, or
pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for
diabetes)