Lymphedema Clinical Trial
Official title:
Pilot Phase I/II Investigational Study to Assess the Efficacy and Safety of Recombinant Hyaluronidase (rHUPH20) in the Treatment of Secondary Lymphedema Resulting From Local Management of Malignancy
This pilot phase I/II 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 may reduce limb edema size in patients with lymphedema.
PRIMARY OBJECTIVES:
I. Safety. II. Tolerability. III. To determine whether recombinant hyaluronidase
(recombinant human hyaluronidase) (rHUPH20) has a role in treatment of secondary lymphedema
resulting from treatment of malignancy.
SECONDARY OBJECTIVES:
I. To evaluate for histologic and/or biomarker correlates of lymphedema or rHUPH20 response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive recombinant human hyaluronidase subcutaneously (SC) on days 1, 3, 5, and 7
(Phase I) and then on days 1-21 (Phase II) in the absence of disease progression or
unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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