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

This study has been completed.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002849
First received: November 1, 1999
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Biological: recombinant interferon alfa
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • response [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).


Enrollment: 93
Study Start Date: November 1996
Study Completion Date: July 2000
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: induction and maintenance
dexamethasone induction followed by alpha interferon maintenance
Biological: recombinant interferon alfa
first 2 years
Other Name: alpha interferon
Drug: dexamethasone
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
Other Name: decadron

Detailed 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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002849

  Show 40 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: Laura F. Hutchins, MD University of Arkansas
Study Chair: Richard A. Larson, MD University of Chicago
  More Information

Additional Information:
Publications:
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.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00002849     History of Changes
Other Study ID Numbers: CDR0000065092, S9628, CLB-9790, CLB-S9628, U10CA032102
Study First Received: November 1, 1999
Last Updated: June 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
primary systemic amyloidosis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Interferons
BB 1101
Interferon-alpha
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014