autologous stem cell transplant in treating patients with progressive or recurrent hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: giving two autologous stem cell transplants (one after the other) may be an effective treatment for hodgkin's lymphoma. purpose: this phase ii trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent hodgkin's lymphoma.

objectives: primary * determine the 3-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 pilot study. patients are stratified according to risk (poor risk \[primary progressive, recurrent, or resistant relapse\] vs good risk \[first recurrence\]). * salvage therapy (for patients with relapsed disease after achieving a previous complete response): patients receive at least 2 courses of salvage chemotherapy or radiotherapy. * 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. * first preparative regimen: patients receive high-dose melphalan iv continuously over 16 hours on day -1. * first autologous stem cell transplantation (sct): patients undergo autologous sct on day 0. they also receive filgrastim (g-csf) iv over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. at least 4-8 weeks later, patients proceed to second preparative regimen. * second preparative regimen: patients receive high-dose carmustine iv over 1-2 hours on days -6, -5, and -4, etoposide iv over 4 hours on day -3, and cyclophosphamide iv over 2 hours on day -2. beginning 36-48 hours later, patients proceed to the second autologous sct (day 0). * second autologous sct: patients undergo second autologous sct on day 0. patients also receive filgrastim (g-csf) iv over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. after completion of study treatment, patients are followed periodically. projected accrual: a total of 34 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically\* confirmed hodgkin's lymphoma meeting ≥ 1 of the following criteria: * disease progression during initial first line chemotherapy * complete response lasting ≤ 90 days after induction * partial response lasting ≤ 90 days after induction * first recurrence/progression with the duration of initial response ≤ 12 months after completion of chemotherapy note: \*there must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression * no clonal abnormalities in marrow collection * must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection * 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) * no cns involvement patient characteristics: performance status * karnofsky 50-100% life expectancy * not specified hematopoietic * not specified hepatic * bilirubin ≤ 1.5 times upper limit of normal\* (uln) note: \*unless due to hodgkin's lymphoma renal * creatinine clearance ≥ 60 ml/min * creatinine ≤ 2.0 times uln cardiovascular * ejection fraction ≥ 45% by 2-d echocardiogram * no significant active cardiac disease pulmonary * adequate pulmonary function * dlco ≥ 45% other * not pregnant or nursing * negative pregnancy test * 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: chemotherapy * see disease characteristics surgery * see disease characteristics

Keywords: recurrent adult hodgkin lymphoma stage iii adult hodgkin lymphoma stage iv adult hodgkin lymphoma