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

Launched by SWOG CANCER RESEARCH NETWORK · Jan 26, 2003

Keywords

ClinConnect Summary

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