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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002849
Other study ID # S9628
Secondary ID S9628CLB-9790CLB
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated March 5, 2015
Start date November 1996
Est. completion date July 2000

Study information

Verified date March 2015
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date July 2000
Est. primary completion date December 1998
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
recombinant interferon alfa
first 2 years
Drug:
dexamethasone
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*

Locations

Country Name City State
United States Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Veterans Affairs Medical Center - Durham Durham North Carolina
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States North Shore University Hospital Manhasset New York
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States Weill Medical College of Cornell University New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Lifespan: The Miriam Hospital Providence Rhode Island
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States Barnes-Jewish Hospital Saint Louis Missouri
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States Lombardi Cancer Center Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Veterans Affairs Medical Center - White River Junction White River Junction Vermont
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Southwest Oncology Group Cancer and Leukemia Group B, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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) S962

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 pri — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary response 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). 10 months No
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