Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
15 Years
70 Years
Both
Lymphoma
Trial Information
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
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-dose therapy with autologous stem cell rescue).
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Salvage therapy (for patients with relapsed disease after achieving a previous complete
response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell
collection.
- Autologous hematopoietic stem cell collection: Patients undergo autologous
hematopoietic stem cell collection. Patients with an inadequate number of collected
stem cells are removed from the study.
- Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after
initial salvage therapy undergo involved-field radiotherapy. All patients then proceed
to the first preparative regimen.
- First preparative regimen: Patients receive high-dose melphalan IV on day -1.
- First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on
day 0. At least 28 days later, patients proceed to second preparative regimen.
- Second preparative regimen: Patients receive 1 of the following preparative regimens:
- Total-body irradiation (TBI)-based regimen: Patients undergo TBI twice daily on
days -8 to -5. Patients also receive etoposide IV over 4 hours on day -4 and
cyclophosphamide IV over 1 hour on day -2.
- Carmustine-based regimen: Patients receive carmustine IV over 2 hours on days -6
to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on
day -2.
- Second autologous SCT: Patients undergo second autologous SCT on day 0. After
completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 7 years.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
2-year Progression-free Survival
Outcome Description:
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Outcome Time Frame:
At day 60, then every 6 months for 2 years
Safety Issue:
No
Principal Investigator
Eileen P. Smith, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000442392
NCT ID:
NCT00233987
Start Date:
October 2005
Completion Date:
February 2016
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
| Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| St. Francis Hospital | Federal Way, Washington 98003 |
| St. Clare Hospital | Lakewood, Washington 98499-0998 |
| Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
| Good Samaritan Cancer Center | Puyallup, Washington 98371 |
| Allenmore Hospital | Tacoma, Washington 98411-0414 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Adventist Medical Center | Portland, Oregon 97216 |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Providence Centralia Hospital | Centralia, Washington 98531-9027 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
| Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
