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| Sponsors and Collaborators: |
Southwest Oncology Group 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 |
Drug: dexamethasone Drug: recombinant interferon alfa |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
| 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 |
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Cancer and Leukemia Group B |
| Study Chair: | Laura F. Hutchins, MD | University of Arkansas |
| Study Chair: | Richard A. Larson, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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.
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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.
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| Study ID Numbers: | CDR0000065092, SWOG-S9628, CLB-9790, CLB-S9628, SWOG-9628 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002849 |
| Health Authority: | United States: Federal Government |
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