Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
Overview
- Phase
- Phase 2
- Intervention
- filgrastim
- Conditions
- Lymphoma
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Progression-free Survival
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: filgrastim
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: busulfan
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: cyclophosphamide
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: etoposide
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: melphalan
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: autologous-autologous tandem hematopoietic stem cell transplantation
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Intervention: radiation therapy
Good Risk
First recurrence patients
Intervention: filgrastim
Good Risk
First recurrence patients
Intervention: busulfan
Good Risk
First recurrence patients
Intervention: cyclophosphamide
Good Risk
First recurrence patients
Intervention: etoposide
Good Risk
First recurrence patients
Intervention: melphalan
Good Risk
First recurrence patients
Intervention: autologous-autologous tandem hematopoietic stem cell transplantation
Good Risk
First recurrence patients
Intervention: radiation therapy
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: 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
Time Frame: One year after second transplant
Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.
Response Rate
Time Frame: 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.