Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	adult	NCI	SWOG-S9628 CLB-9790, CLB-S9628, SWOG-9628, S9628, NCT00002849

Objectives

1. Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa.
2. Identify prognostic factors that may relate to response and overall survival in these patients.
3. Evaluate the qualitative and quantitative toxic effects of this regimen.

Entry 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

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

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

Expected Enrollment

A total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 years.

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.

Dhodapkar MV, Hussein MA, Rasmussen E, et al.: 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 104 (12): 3520-6, 2004.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Laura Hutchins, MD, Protocol chair		Ph: 501-686-8511 Email: hutchinslauraf@uams.edu

Cancer and Leukemia Group B

Richard Larson, MD, Protocol chair		Ph: 773-702-6783

Registry Information
Official Title		PHASE II STUDY OF DEXAMETHASONE/ALPHA-INTERFERON IN AL AMYLOIDOSIS
Trial Start Date		1996-11-01
Registered in ClinicalTrials.gov		NCT00002849
Date Submitted to PDQ		1996-11-01
Information Last Verified		2003-05-14
NCI Grant/Contract Number		CA32102