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

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Interferon-alpha; Interferons

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