NCT01928030

Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

Pilot Phase 1-2 Investigational Study to Assess the Efficacy and Safety of Recombinant Hyaluronidase (rHUPH20) in the Treatment of Secondary Lymphedema Resulting From Local Management of Malignancy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lymphedema
• Malignant Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	recombinant human hyaluronidase	Given SC

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-08-23
• Last updated: 2017-03-21
• Results posted: 2017-02-07

Locations

1 site across 1 country: United States