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S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00109889
Collaborator
National Cancer Institute (NCI) (NIH)
2
Enrollment
26
Locations
1
Arm
24
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 clinical trial is studying MRI and ^18FDG-PET to see how well they work in diagnosing patients with solitary plasmacytoma.

Condition or Disease Intervention/Treatment Phase
  • Procedure: magnetic resonance imaging
  • Procedure: positron emission tomography
 Phase 2

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 imaging with skeletal survey.

  • Determine the feasibility of accruing patients to this study.

  • Determine, preliminarily, biological correlates and prognostic groups that may relate to progression to symptomatic disease in patients undergoing these imaging procedures.

  • Correlate germline genetic polymorphisms with overall clinical course in patients undergoing these imaging procedures.

OUTLINE: This is a multicenter study.

Within 28 days after study entry, patients undergo gadolinium MRI of the head, spine, and pelvis (and other sites, if indicated). Patients then receive fludeoxyglucose F 18 IV followed 90 minutes later by whole-body positron emission tomography (^18FDG-PET) OR whole-body CT scan/PET. Patients with a confirmed diagnosis of solitary plasmacytoma undergo MRI and ^18FDG-PET as above at 1 year and then annually for 10 years in the absence of disease progression (i.e., change of status to solitary plasmacytoma with active myeloma or biopsy confirmed stage IB or higher multiple myeloma).

After completion of study procedures, patients are followed every 6 months for 10 years.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Other: MRI and PET

Magnetic resonance imaging and positron emission tomography

Procedure: magnetic resonance imaging
magnetic resonance imaging (MRI)
Other Names:
  • MRI

    • Procedure: positron emission tomography
    positron emission tomography (PET)
    Other Names:
  • PET

    		•

    Outcome Measures

    Primary Outcome Measures

    1. proportion of patients misclassified as solitary plasmacytoma [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    6 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
    7 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    8 St. Vincent Healthcare Billings Montana United States 59101
    9 Billings Clinic Cancer Center Billings Montana United States 59107-5100
    10 Deaconess Billings Clinic - Downtown Billings Montana United States 59107-7000
    11 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
    12 St. James Community Hospital Butte Montana United States 59701
    13 Big Sky Oncology Great Falls Montana United States 59405
    14 Sletten Regional Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
    15 St. Peter's Hospital Helena Montana United States 59601
    16 Glacier Oncology, PLLC Kalispell Montana United States 59901
    17 Kalispell Medical Oncology Kalispell Montana United States 59901
    18 Kalispell Regional Medical Center Kalispell Montana United States 59901
    19 Community Medical Center Missoula Montana United States 59801
    20 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    21 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
    22 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
    23 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
    24 Wayne Radiation Oncology Goldsboro North Carolina United States 27534
    25 Wilson Medical Center Wilson North Carolina United States 27893-3428
    26 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Andrzej J. Jakubowiak, MD, PhD, University of Michigan Rogel Cancer Center
    • Study Chair: Janet S. Biermann, MD, University of Michigan Rogel Cancer Center
    • Study Chair: Paul Okunieff, MD, James P. Wilmot Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00109889
    Other Study ID Numbers:
    • CDR0000426422
    • U10CA032102
    • S0340
    First Posted:
    May 4, 2005
    Last Update Posted:
    Apr 24, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Southwest Oncology Group
    extramedullary plasmacytoma
    isolated plasmacytoma of bone
    Additional relevant MeSH terms:
    Multiple Myeloma
    Plasmacytoma

    Study Results

    No Results Posted as of Apr 24, 2017