Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Laura Fulper Hutchins

Study Chair

Richard A. Larson

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002849
Information obtained from ClinicalTrials.gov on November 20, 2012

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