S9805, High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstrom's Macroglobulinemia
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Immunologically diagnosed Waldenstrom's macroglobulinemia (WM) Evaluable quantifiable IgM One of the following criteria must be met: 1) Patient demonstrates clinical symptoms such as fatigue, dizziness, visual inacuity, or hemorrhagic manifestations of WM with anemia, hyperviscosity, thrombocytopenia, or coagulopathies 2) Advanced tumor mass present involving ONE of the following: Extensive lymphadenopathy (greater than 2 cm) Hepato or splenomegaly palpable on clinical examination Marked bone marrow infiltration greater than 50% 3) Progressive disease; i.e., increase in IgM concentration by at least 50%, and/or a drop of greater than 2 g/dL in hemoglobin (in the absence of gastrointestinal bleeding), and/or a greater than 50,000/mm3 decrease in platelets PATIENT CHARACTERISTICS: Age: Under 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: At least 6 months since myocardial infarction No congestive heart failure No arrhythmia refractory to therapy Ejection fraction within normal range by MUGA or ECHO Pulmonary: FEV1 at least 50% of predicted DLCO at least 50% of predicted Other: Not pregnant or nursing Effective contraception required of fertile patients No significant comorbid condition No uncontrolled life-threatening infection No uncontrolled diabetes No other malignancy within past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or adequately treated stage I or II cancer currently in remission HIV negative Hepatitis B surface antigen negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Sites / Locations
- MBCCOP - University of South Alabama
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- Beckman Research Institute, City of Hope
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- University of California Davis Medical Center
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- Veterans Affairs Medical Center - Denver
- University of Colorado Cancer Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- CCOP - Central Illinois
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Medical Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Hospital - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- University of Michigan Comprehensive Cancer Center
- Veterans Affairs Medical Center - Detroit
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- Providence Hospital - Southfield
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- University of New Mexico Cancer Research & Treatment Center
- Veterans Affairs Medical Center - Brooklyn
- Herbert Irving Comprehensive Cancer Center
- Barrett Cancer Center, The University Hospital
- Veterans Affairs Medical Center - Cincinnati
- Cleveland Clinic Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Oregon Cancer Center at Oregon Health Sciences University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- CCOP - Greenville
- CCOP - Upstate Carolina
- Brooke Army Medical Center
- University of Texas Medical Branch
- Texas Tech University Health Science Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
Arms of the Study
Arm 1
Experimental
treatment
Ind: dexamethasone 40 mg/d PO D1-4,9-12,17-20 q35 days x 3 cycles SC Collection: cyclophosphamide 1.5gm/m2 IV q3 hrs x 2 mesna 3 gm/m2 conIV start with cyclo GCSF 5mcg/kg/d SQ start 1 day after cyclo until WBC > 50,000/mcg Trans (x2): melphalan 100 mg/m2/d IV D-1,-2 PBSC infusion D0 Maint: interferon 3 million units/m2 SQ 3x/wk