S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis

NCT00002849 | Completed Phase 2 DMC

• 4 other identifiers: S9628CLB-9790CLB-S9628U10CA032102
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 40

Brief Summary

RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.

Conditions

Multiple Myeloma

Keywords

primary systemic amyloidosis

Outcome Measures

Primary Outcomes (1)

• response

  50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).

  10 months

Study Arms (1)

induction and maintenance

EXPERIMENTAL

dexamethasone induction followed by alpha interferon maintenance

Biological: recombinant interferon alfa; Drug: dexamethasone

Interventions

recombinant interferon alfa BIOLOGICAL

first 2 years

Also known as: alpha interferon

induction and maintenance

dexamethasone DRUG

40 mg\*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles\*

Also known as: decadron

induction and maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (40)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (2)

• 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.

  PMID: 15308571 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis

Interventions

Interferon-alpha; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Laura F. Hutchins, MD

  University of Arkansas

  STUDY CHAIR

• Richard A. Larson, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1996
• Primary Completion: December 1, 1998
• Study Completion: July 1, 2000
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (40)