Clinical trial NCT00265889
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma
Sponsor: Case Comprehensive Cancer Center
Start date: 2002-02-01; Completion date: 2010-04-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Primary progressive, recurrent, or resistant relapse patients arm 2: First recurrence patients
Interventions: intervention 1: filgrastim intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: etoposide intervention 5: melphalan intervention 6: autologous-autologous tandem hematopoietic stem cell transplantation intervention 7: radiation therapy
Intervention descriptions: intervention 1: 480 mcg beginning day +5 intervention 2: 11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses intervention 3: 60 mg/kg IV over 2 hours x 2 days intervention 4: 60 mg/kg, IV intervention 5: 150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes. intervention 6: autologous-autologous tandem hematopoietic stem cell transplantation intervention 7: radiation therapy

Protocol documents: