NCT00233987

S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

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

Timeline

• Start date: 2005-10-01
• Primary completion: 2014-11-01
• Completion: 2017-12-01
• First posted: 2005-10-06
• Last updated: 2018-03-01
• Results posted: 2013-02-05

Locations

53 sites across 1 country: United States