This trial is active, not recruiting.

Condition lymphoma
Treatments carmustine, cyclophosphamide, etoposide, melphalan, autologous-autologous tandem hematopoietic stem cell transplantation, radiation therapy
Phase phase 2
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date October 2005
End date February 2011
Trial size 98 participants
Trial identifier NCT00233987, CDR0000442392, S0410, U10CA032102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
carmustine BCNU
150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
100 mg/kg IV 2 days before transplant.
60 mg/kg IV over 4 hours 4 days before transplant.
150 mg/m^2 IV 1 day before transplant.
autologous-autologous tandem hematopoietic stem cell transplantation
2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.
radiation therapy Total body irradiation (TBI)
150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.

Primary Outcomes

2-year Progression-free Survival
time frame: At day 60, then every 6 months for 2 years

Secondary Outcomes

Response Rate
time frame: At day 60, then every 6 months for 2 years
Overall Survival
time frame: At day 60, then every 6 months for 2 years, then annually for a total of 7 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
time frame: Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion

Eligibility Criteria

Male or female participants from 15 years up to 70 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed Hodgkin's lymphoma - Relapsed or refractory disease - Biopsy or radiological evidence of disease at time of recurrence/progression required - Has received ≥ 1 prior systemic chemotherapy regimen - No clonal abnormalities in marrow collection - Must undergo involved-field radiotherapy if bulky disease > 5 cm - Must have adequate sections of original diagnostic specimen available for review - Needle aspirations or cytologies are not adequate - No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free > 5 years) - Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present - No central nervous system (CNS) involvement PATIENT CHARACTERISTICS: Age - 15 to 70 Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease) Renal - Creatinine clearance ≥ 60 mL/min - Creatinine ≤ 2 times upper limit of normal Cardiovascular - None of the following conditions requiring therapy: - Coronary artery disease - Cardiomyopathy - Congestive heart failure - Arrhythmias - Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram Pulmonary - Adequate pulmonary function - Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR - Forced Expiratory Volume in One Side (FEV_1) ≥ 60% of predicted Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer - No known HIV or AIDS infection - No active bacterial, fungal, or viral infection - No medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified

Additional Information

Official title Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.