Completed

Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis

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What is being tested

recombinant interferon alfa

+ dexamethasone

BiologicalDrug
Who is being recruted

Amyloidosis+17

+ Blood Protein Disorders

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1996
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: March 6, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00002849
Principal SponsorSWOG Cancer Research Network
Last updated: March 6, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

93 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisBlood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNutritional and Metabolic DiseasesParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellProteostasis DeficienciesImmunoglobulin Light-chain AmyloidosisMultiple Myeloma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
dexamethasone induction followed by alpha interferon maintenance

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 40 locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, United StatesOpen Rebecca and John Moores UCSD Cancer Center in Google Maps

Veterans Affairs Medical Center - San Francisco

San Francisco, United States

CCOP - Christiana Care Health Services

Wilmington, United States

Lombardi Cancer Center

Washington D.C., United States
Completed40 Study Centers