Status:
TERMINATED
Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Musculoskeletal Complications
Eligibility:
MALE
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma. PURPOSE: This...
Detailed Description
OBJECTIVES: Primary * To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagno...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed high-grade glioma, including the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Requires dexamethasone at a dose of \> 4 mg/day to control symptoms of tumor-related edema at time of study enrollment AND has been on a stable dose of steroids for ≥ 5 days prior to study enrollment
- Completed ≥ 80% of prescribed radiotherapy
- Hypogonadal, defined as serum testosterone level \< 350 ng/dL
- No history of prostate or breast cancer
- No benign prostatic hypertrophy requiring therapy OR AUA score of ≥ 8
- PSA ≤ 4 ng/mL
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Able to keep daily records or has a care provider that agrees to keep daily records of drug administration
- No clinical history of congestive heart failure requiring therapy
- No psychotic disorder requiring active treatment
- No structured exercise program involving exercise for \> 3 hours/week
- No polycythemia (i.e., hematocrit \> 52%)
- PRIOR CONCURRENT THERAPY:
- More than 6 months since prior androgen therapy
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00631137
Start Date
January 1 2008
End Date
September 1 2008
Last Update
August 27 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410