S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Procedure: autologous-autologous tandem hematopoietic stem cell transplantationRadiation: radiation therapy
- Registration Number
- NCT00233987
- Lead Sponsor
- SWOG Cancer Research Network
- 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 stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.
- 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-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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-dose therapy plus tandem transplant autologous-autologous tandem hematopoietic stem cell transplantation Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. High-dose therapy plus tandem transplant radiation therapy Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. High-dose therapy plus tandem transplant melphalan Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. High-dose therapy plus tandem transplant cyclophosphamide Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. High-dose therapy plus tandem transplant etoposide Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. High-dose therapy plus tandem transplant carmustine Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
- Primary Outcome Measures
Name Time Method 2-year Progression-free Survival At day 60, then every 6 months for 2 years Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
- Secondary Outcome Measures
Name Time Method Response Rate At day 60, then every 6 months for 2 years Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Overall Survival At day 60, then every 6 months for 2 years, then annually for a total of 7 years Measured from date of registration to date of death due to any cause or last contact
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Trial Locations
- Locations (53)
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Adventist Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸Portland, Oregon, United States