This phase 1-2 trial studies the side effects and the best dose of recombinant human hyaluronidase and to see how well it works in treating lymphedema in patients with cancer. Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in patients with lymphedema.
This is a phase 1, dose-escalation study followed by a phase 2 study. Phase 1: rHuPH20 subcutaneously (SC) on days 1, 3, 5, and 7 Phase 2: rHuPH20 SC on days 1 to 21
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
Given SC
Stanford University Hospitals and Clinics
Stanford, California, United States
Treatment-related Adverse Events
Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment
Time frame: Up to 1 year
Reduction in Forearm Volume
Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume
Time frame: Up to 1 year
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