S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
NCT ID: NCT00002849
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
93 participants
INTERVENTIONAL
1996-11-30
2000-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.
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Detailed Description
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* Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa.
* Identify prognostic factors that may relate to response and overall survival in these patients.
* Evaluate the qualitative and quantitative toxic effects of this regimen.
OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no).
All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20 every 35 days for a total of 3 courses.
Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell harvest) of initiation of the third course of induction, as follows: oral dexamethasone for 4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa.
Combination therapy is continued until 2 years from entry; thereafter, interferon is administered alone for at least 3 years, toxicity permitting. Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician.
Patients are followed every 6 months for 2 years and yearly thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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induction and maintenance
dexamethasone induction followed by alpha interferon maintenance
recombinant interferon alfa
first 2 years
dexamethasone
40 mg\*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles\*
Interventions
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recombinant interferon alfa
first 2 years
dexamethasone
40 mg\*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles\*
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically diagnosed primary systemic amyloidosis based on the following:
* Deposition of fibrillary protein with Congo red positive stain or characteristic electron microscopic appearance
* Monoclonal light chain protein (Bence-Jones protein) in serum or urine or immunohistochemical studies
* Evidence of tissue involvement other than carpal tunnel syndrome
* Diagnostic histologic material available for central pathology review
* Confirmation of tissue diagnosis at all sites of organ dysfunction encouraged
* No senile, secondary, localized, dialysis-related, or familial amyloidosis
* No known therapy-related myelodysplasia
PATIENT CHARACTERISTICS:
Age:
* Adult
Performance status:
* SWOG 0-4
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No NYHA class IV status
Other:
* No uncontrolled diabetes
* No active peptic ulcer disease
* No medical condition that precludes high-dose steroids
* No second malignancy within 5 years except:
* Adequately treated nonmelanomatous skin cancer
* In situ cervical cancer
* Adequately treated stage I/II cancer in complete remission
* Not pregnant or nursing
* Effective contraception required of fertile patients
* Blood/body fluid analyses within 14 days prior to registration
* Imaging/exams for tumor measurement within 28 days prior to registration
* Other screening exams within 42 days prior to registration
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior interferon alfa
Chemotherapy
* Prior melphalan allowed, but recovered from effects
* At least 4 weeks since cytotoxic therapy and recovered
Endocrine therapy
* Prior prednisone allowed, but recovered from effects
* At least 4 weeks since prior glucocorticoids
* No prior dexamethasone
* No planned or concurrent dexamethasone or other therapy for primary systemic amyloidosis
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Laura F. Hutchins, MD
Role: STUDY_CHAIR
University of Arkansas
Richard A. Larson, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Dhodapkar MV, Hussein MA, Rasmussen E, Solomon A, Larson RA, Crowley JJ, Barlogie B; United States Intergroup Trial Southwest Oncology Group. Clinical efficacy of high-dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup Trial Southwest Oncology Group (SWOG) S9628. Blood. 2004 Dec 1;104(12):3520-6. doi: 10.1182/blood-2004-05-1924. Epub 2004 Aug 12.
Dhodapkar M, Jacobson J, Hussein M, et al.: High dose dexamethasone (Dex) with maintenance Dex / alpha interferon leads to improved survival in patients with primary systemic amyloidosis: results of US Intergroup Trial Southwest Oncology Group (SWOG) S9628. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2278, 2003.
Other Identifiers
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S9628
Identifier Type: OTHER
Identifier Source: secondary_id
CLB-9790
Identifier Type: OTHER
Identifier Source: secondary_id
CLB-S9628
Identifier Type: OTHER
Identifier Source: secondary_id
S9628
Identifier Type: -
Identifier Source: org_study_id
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