Search / Trial NCT00002849

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

Launched by SWOG CANCER RESEARCH NETWORK · Jan 26, 2003

Trial Information

Current as of November 03, 2024

Completed

Keywords

Primary Systemic Amyloidosis

Description

OBJECTIVES: * 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 th...

Gender

ALL

Eligibility criteria

  • 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

About Swog Cancer Research Network

The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.

Locations

New York, New York, United States

Buffalo, New York, United States

New York, New York, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

Minneapolis, Minnesota, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Burlington, Vermont, United States

Las Vegas, Nevada, United States

Wilmington, Delaware, United States

Miami Beach, Florida, United States

Columbia, Missouri, United States

Saint Louis, Missouri, United States

Lebanon, New Hampshire, United States

Manhasset, New York, United States

Syracuse, New York, United States

Winston Salem, North Carolina, United States

Richmond, Virginia, United States

New York, New York, United States

Winston Salem, North Carolina, United States

White River Junction, Vermont, United States

Boston, Massachusetts, United States

Manhasset, New York, United States

Chicago, Illinois, United States

San Francisco, California, United States

Iowa City, Iowa, United States

Syracuse, New York, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

La Jolla, California, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Washington, District Of Columbia, United States

Providence, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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