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

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ClinicalTrials.gov Identifier: NCT00002849
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: recombinant interferon alfa Drug: dexamethasone Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
Study Start Date : November 1996
Actual Primary Completion Date : December 1998
Actual Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. response [ Time Frame: 10 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002849


  Show 40 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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
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Publications of Results:
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: S9628
S9628 ( Other Identifier: SWOG )
CLB-9790 ( Other Identifier: CALGB )
CLB-S9628 ( Other Identifier: CALGB )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Southwest Oncology Group:
primary systemic amyloidosis

Additional relevant MeSH terms:
Multiple Myeloma
Amyloidosis
Neoplasms, Plasma Cell
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
Interferons
BB 1101
Interferon-alpha
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones