Clinical trial NCT00233987
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma
Sponsor: SWOG Cancer Research Network
Start date: 2005-10-01; Completion date: 2017-12-01
Enrollment: 98 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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.
Interventions: intervention 1: carmustine intervention 2: cyclophosphamide intervention 3: etoposide intervention 4: melphalan intervention 5: autologous-autologous tandem hematopoietic stem cell transplantation intervention 6: radiation therapy
Intervention descriptions: intervention 1: 150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant. intervention 2: 100 mg/kg IV 2 days before transplant. intervention 3: 60 mg/kg IV over 4 hours 4 days before transplant. intervention 4: 150 mg/m\^2 IV 1 day before transplant. intervention 5: 2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion. intervention 6: 150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.

Protocol documents: