Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: filgrastimProcedure: autologous-autologous tandem hematopoietic stem cell transplantationRadiation: radiation therapy
- Registration Number
- NCT00265889
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 3-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 pilot study. Patients are stratified according to risk (poor risk \[primary progressive, recurrent, or resistant relapse\] vs good risk \[first recurrence\]).
* Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
* 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.
* First preparative regimen: Patients receive high-dose melphalan IV continuously over 16 hours on day -1.
* First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients proceed to second preparative regimen.
* Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over 2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second autologous SCT (day 0).
* Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Good Risk cyclophosphamide First recurrence patients Poor Risk filgrastim Primary progressive, recurrent, or resistant relapse patients Poor Risk autologous-autologous tandem hematopoietic stem cell transplantation Primary progressive, recurrent, or resistant relapse patients Poor Risk radiation therapy Primary progressive, recurrent, or resistant relapse patients Good Risk filgrastim First recurrence patients Good Risk autologous-autologous tandem hematopoietic stem cell transplantation First recurrence patients Good Risk radiation therapy First recurrence patients Poor Risk busulfan Primary progressive, recurrent, or resistant relapse patients Poor Risk cyclophosphamide Primary progressive, recurrent, or resistant relapse patients Poor Risk etoposide Primary progressive, recurrent, or resistant relapse patients Poor Risk melphalan Primary progressive, recurrent, or resistant relapse patients Good Risk busulfan First recurrence patients Good Risk etoposide First recurrence patients Good Risk melphalan First recurrence patients
- Primary Outcome Measures
Name Time Method Progression-free Survival one year after second transplant Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.
Number of Patients That Experience Pulmonary Toxicity One year after second transplant Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.
Response Rate One year after second transplant Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as \>/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States