Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
- 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
- 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
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2-year Progression-free Survival
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
At day 60, then every 6 months for 2 years
Eileen P. Smith, MD
Beckman Research Institute
United States: Federal Government
|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|