Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Male

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 randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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