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.
- biological : recombinant human hyaluronidase
- other : pharmacological study
- other : laboratory biomarker analysis
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2 - Unilateral upper limb secondary lymphedema - Women of child bearing potential must have a documented negative pregnancy test within 2 weeks prior to day 1 of treatment and agree to use a non-hormonal form of birth control during the duration of the trial therapy - Patients, or legal representative, must have the ability to understand and the willingness to sign a written informed consent document - Patient or legal representative must agree to blood serum assessment including, complete blood count (CBC) with differential; comprehensive metabolic panel and serum osmolality at every sanctioned evaluation; additionally physician may require cardiac evaluation with echocardiogram, electrocardiogram, brain natriuretic peptide or urinalysis if deemed appropriate - Patient or legal representative must consent to multi-bio-frequency impedance analysis (MFBIA); the details are to be covered in consent - Patient or legal guardian willing to sign consent for skin biopsies and phlebotomy