Status:
COMPLETED
Combination Chemotherapy Followed By Autologous Stem Cell Transplant, and White Blood Cell Infusions in Treating Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
Brief 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 th...
Detailed Description
OBJECTIVES: * Determine the toxicity of high-dose combination chemotherapy comprising cyclophosphamide, thiotepa, and carboplatin followed by autologous peripheral blood stem cell transplantation and...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00244946
Start Date
March 1 2004
End Date
March 1 2013
Last Update
March 26 2015
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379