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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00109889
Other study ID # CDR0000426422
Secondary ID U10CA032102S0340
Status Terminated
Phase Phase 2
First received May 3, 2005
Last updated April 21, 2017
Start date April 2005
Est. completion date April 2007

Study information

Verified date April 2017
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
magnetic resonance imaging
magnetic resonance imaging (MRI)
positron emission tomography
positron emission tomography (PET)

Locations

Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Billings Clinic Cancer Center Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Deaconess Billings Clinic - Downtown Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Billings Montana
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States St. James Community Hospital Butte Montana
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Big Sky Oncology Great Falls Montana
United States Sletten Regional Cancer Institute at Benefis Healthcare Great Falls Montana
United States St. Peter's Hospital Helena Montana
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Mobile Infirmary Medical Center Mobile Alabama
United States Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Wilson Medical Center Wilson North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of patients misclassified as solitary plasmacytoma 2 months
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