NCT00233987
S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
PHASE2
COMPLETED
NCT00233987
INTERVENTIONAL
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
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.
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
Lymphoma
- TREATMENT
-
- Type: DRUG
- Name: carmustine
- Description: 150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant.
- Arm Group Labels: High-dose therapy plus tandem transplant
-
- Type: DRUG
- Name: cyclophosphamide
- Description: 100 mg/kg IV 2 days before transplant.
- Arm Group Labels: High-dose therapy plus tandem transplant
-
- Type: DRUG
- Name: etoposide
- Description: 60 mg/kg IV over 4 hours 4 days before transplant.
- Arm Group Labels: High-dose therapy plus tandem transplant
-
- Type: DRUG
- Name: melphalan
- Description: 150 mg/m\^2 IV 1 day before transplant.
- Arm Group Labels: High-dose therapy plus tandem transplant
-
- Type: PROCEDURE
- Name: autologous-autologous tandem hematopoietic stem cell transplantation
- Description: 2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.
- Arm Group Labels: High-dose therapy plus tandem transplant
-
- Type: RADIATION
- Name: radiation therapy
- Description: 150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
- Arm Group Labels: High-dose therapy plus tandem transplant
- SWOG Cancer Research Network