S9805, High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstrom's Macroglobulinemia
NCT ID: NCT00003416
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
1998-09-30
2004-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's macroglobulinemia.
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Detailed Description
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OUTLINE: Regimen A (dexamethasone induction): All patients receive high dose dexamethasone orally on days 1-4, 9-12, and 17-20; courses repeat every 35 days for a total of 3 courses. Regimen B (stem cell mobilization and collection): Following a 4-6 week break after dexamethasone induction and regardless of response or progression, patients have stem cells collected following administration of filgrastim (G-CSF) by injection; G-CSF continues until completion of stem cell collection (maximum of 6 aphereses). Regimen C (first peripheral blood stem cell transplant (PBSCT)): Regardless of disease progression, patients recovered from toxicities from dexamethasone induction and stem cell mobilization and collection, and who have adequate number of CD34 cells collected for at least 1 transplant, receive 1 dose of melphalan daily for 2 days followed by peripheral stem cell reinfusion. G-CSF is given by injection beginning on the day after peripheral stem cell reinfusion and continues until the absolute granulocyte count is greater than 1,000/mm3 on 3 consecutive days. Regimen D (second PBSCT): Patients who had adequate stem cell collection for 2 transplants during regimen B, have no evidence of disease progression after the first transplant, and have recovered from effects of previous treatment undergo a second treatment with high dose melphalan with PBSCT and G-CSF support, given 3-12 months following the first transplant. Patients who had enough cells collected for only one transplant go directly to regimen E. Regimen E (maintenance interferon alfa): Beginning 5-12 weeks after transplant and upon hematologic recovery of blood counts and other toxicities, patients with at least a partial response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections 3 times a week for 5 years or until disease progression, relapse, or toxicity. Patients are followed every month for 6 months, then every 3 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over 4 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
filgrastim
recombinant interferon alfa
dexamethasone
melphalan
peripheral blood stem cell transplantation
Interventions
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filgrastim
recombinant interferon alfa
dexamethasone
melphalan
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
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
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Madhav Dhodapkar, MD
Role: STUDY_CHAIR
Rockefeller University
Locations
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MBCCOP - University of South Alabama
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
Beckman Research Institute, City of Hope
Duarte, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
University of California Davis Medical Center
Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Louisiana State University Hospital - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
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Other Identifiers
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S9805
Identifier Type: OTHER
Identifier Source: secondary_id
S9805
Identifier Type: -
Identifier Source: org_study_id
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