Status:
TERMINATED
S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Plasmacytoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and fludeoxyglucose F 18 positron emission tomography (\^18FDG-PET) may help diagnose solitary plasmacytoma. PURPOSE: This c...
Detailed Description
OBJECTIVES: * Determine the proportion of patients who are misclassified as true solitary plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as a supplement to imagi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed solitary plasmacytoma of 1 of the following types:
- Solitary bone plasmacytoma
- Extraosseus solitary plasmacytoma
- Bone marrow plasmacytosis \< 10% within the past 4 weeks
- Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:
- Serum IgG \< 3.5 g/dL
- Serum IgA \< 2.0 g/dL
- Urine M-protein (kappa or lambda) \< 1.0 g/24 hours
- No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Hemoglobin ≥ 10 g/dL\* AND/OR
- No hemoglobin 2 g/dL \< lower limit of normal\* (LLN) NOTE: \*Patients with a history of hemoglobin \< 10 g/dL AND/OR \< 2 g/dL \< LLN that has corrected or improved after epoetin alfa but requires continued treatment with epoetin alfa are not eligible
- Hepatic
- Not specified
- Renal
- Calcium ≤ 10.5 mg/dL OR
- Calcium normal
- Creatinine ≤ 2 mg/dL
- Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage I or II cancer that is currently in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- No prior high-dose steroids except to relieve neurological compromise
- Radiotherapy
- Prior localized radiotherapy for myeloma allowed
- Concurrent radiotherapy allowed
- Surgery
- Prior surgery for myeloma allowed
- Other
- No other prior therapy for myeloma
- Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00109889
Start Date
April 1 2005
End Date
April 1 2007
Last Update
April 24 2017
Active Locations (26)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
4
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942