Status:
COMPLETED
S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
15-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopp...
Detailed Description
OBJECTIVES: * Determine the 2-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-d...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed Hodgkin's lymphoma
- Relapsed or refractory disease
- Biopsy or radiological evidence of disease at time of recurrence/progression required
- Has received ≥ 1 prior systemic chemotherapy regimen
- No clonal abnormalities in marrow collection
- Must undergo involved-field radiotherapy if bulky disease \> 5 cm
- Must have adequate sections of original diagnostic specimen available for review
- Needle aspirations or cytologies are not adequate
- No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free \> 5 years)
- Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present
- No central nervous system (CNS) involvement
- PATIENT CHARACTERISTICS:
- Age
- 15 to 70
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease)
- Renal
- Creatinine clearance ≥ 60 mL/min
- Creatinine ≤ 2 times upper limit of normal
- Cardiovascular
- None of the following conditions requiring therapy:
- Coronary artery disease
- Cardiomyopathy
- Congestive heart failure
- Arrhythmias
- Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram
- Pulmonary
- Adequate pulmonary function
- Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR
- Forced Expiratory Volume in One Side (FEV\_1) ≥ 60% of predicted
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
- No known HIV or AIDS infection
- No active bacterial, fungal, or viral infection
- No medical condition that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00233987
Start Date
October 1 2005
End Date
December 1 2017
Last Update
March 1 2018
Active Locations (53)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817
2
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
3
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720