Full Text View
Tabular View
No Study Results Posted
Related Studies
Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002849
  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 and Plasma Cell Neoplasm
Biological: recombinant interferon alfa
Drug: dexamethasone
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: PHASE II STUDY OF DEXAMETHASONE/ALPHA-INTERFERON IN AL AMYLOIDOSIS

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 100
Study Start Date: November 1996
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
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 MV, Hussein MA, Rasmussen E, Solomon A, Larson RA, Crowley JJ, Barlogie B; United States Intergroup Trial Southwest Oncology Group. 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. 2004 Dec 1;104(12):3520-6. Epub 2004 Aug 12.
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.

Study ID Numbers: CDR0000065092, SWOG-S9628, CLB-9790, CLB-S9628, SWOG-9628
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002849     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
primary systemic amyloidosis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Interferon-alpha
Neoplasms by Histologic Type
Metabolic Diseases
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Interferons
Gastrointestinal Agents
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009