Expired Study
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Boston, Massachusetts 02118


Purpose:

RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.


Study summary:

OBJECTIVES: Primary - Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis. - Determine the objective hematologic response rate in patients treated with this drug. - Determine amyloid organ disease response in patients treated with this drug. Secondary - Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone. - Determine the toxicity of CC-5013 in combination with dexamethasone in these patients. OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study. Patients are followed annually. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.


Criteria:

Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary systemic (AL) amyloidosis - Tissue amyloid deposits or positive fat aspirate - Meets 1 of the following criteria for AL type disease: - Serum or urine monoclonal protein by immunofixation electrophoresis - Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype PATIENT CHARACTERISTICS: Age - 18 and over Performance status - SWOG 0-2 Life expectancy - Not specified Hematopoietic - WBC > 3,000/mm^3 - Hemoglobin > 8 g/dL - Platelet count > 100,000/mm^3 - Absolute neutrophil count > 1,000/mm^3 Hepatic - Bilirubin ≤ 2 times upper limit of normal (ULN) - AST and ALT ≤ 2 times ULN PRIOR CONCURRENT THERAPY: Biologic therapy - Prior thalidomide for AL amyloidosis allowed Chemotherapy - More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy - Prior steroids for AL amyloidosis allowed Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - Prior surgery allowed Other - Recovered from all prior therapy Exclusion Criteria: - No secondary or familial amyloidosis - No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions - No prior CC-5013 Renal - No dialysis Cardiovascular - No symptomatic cardiac arrhythmia - No oxygen-dependent restrictive cardiomyopathy Other - No untreated or uncontrolled infection - No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast - No other serious medical illness that would preclude study participation - No history of hypersensitivity reaction to thalidomide - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception


NCT ID:

NCT00091260


Primary Contact:

Principal Investigator
David C. Seldin, MD, PhD
Boston Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02118
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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