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Gottlieb Memorial Hospital

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NCT00233987

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

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/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
Sponsor
  • SWOG Cancer Research Network