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Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis Clinical research trials and Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis. Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis clinical trial. Subjects frequently get the best healthcare possible for their Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis  Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis
Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis
For Condition: primary systemic amyloidosis
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI),Cancer and Leukemia Group B
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LauraHutchins, Study Chair, University of Arkansas
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Additional Information:
Study ID Numbers: CDR0000065092; SWOG-S9628,CLB-9790,CLB-S9628,SWOG-9628
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002849
Other Primary Systemic Amyloidosis Studies:
1. Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis
2. Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
3. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
4. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
5. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Related Studies:
Other primary systemic amyloidosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis
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