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| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 1996 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically diagnosed primary systemic amyloidosis based on the following:
Diagnostic histologic material available for central pathology review
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 40 Study Locations| Study Chair: | Laura F. Hutchins, MD | University of Arkansas |
| Study Chair: | Richard A. Larson, MD | University of Chicago |
More Information
| 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 |
|
primary systemic amyloidosis |
|
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 |