Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

Not Recruiting

Trial ID: NCT01928030


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.

Official Title

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

Stanford Investigator(s)

Stanley G. Rockson, MD
Stanley G. Rockson, MD

Allan and Tina Neill Professor of Lymphatic Research and Medicine

Mark Pegram

Susy Yuan-Huey Hung Professor


Inclusion Criteria:

   - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2

   - Unilateral upper limb secondary lymphedema

   - Must have the ability to understand and the willingness to sign a written informed
   consent document

   - 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

   - Must consent to multi-bio-frequency impedance analysis (MFBIA); the details are to be
   covered in consent

   - Willing to sign consent for skin biopsies and phlebotomy

   - 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

Exclusion Criteria:

   - Pregnant or actively breast-feeding

   - Bilateral upper extremity edema

   - Bilateral manipulation of axilla within the last 24 months

   - Active infections

   - Receiving concomitant treatment for upper extremity lymphedema, or who have received
   treatment within the last 14 days

   - Known allergic or hypersensitivity reaction to rHUPH20 or any hyaluronidase extracts

   - Receiving concomitant diuretics or dihydropyridine class of calcium channel blockers;
   if an alternative medication is available, patient can become eligible after 3
   half-lives of drug discontinued and patient remains medically stable

   - Grade 2 or greater hypo-albuminemia, serum sodium greater than 150meq/L, serum
   osmolality greater than 300mOsm/kg or blood urea nitrate/serum creatinine ratio
   greater than 25, within 7 days of screening

   - Unable or unwilling to self/home administer subcutaneous experimental drug; study
   nurse or physician will train individuals on proper administration techniques

   - Unwilling or incapable of maintaining a detailed log of number of injections, the
   date, time and site of administration

   - Active malignancy; those undergoing active treatment for malignancy in the adjuvant
   setting are eligible; treatment can include chemotherapy, targeted therapy or
   anti-hormonal therapy

   - At least 4 weeks removed from surgery or radiation in affected arm

   - Primary lymphedema; if edema can be explained by systemic or congenital illnesses,
   that patient will not be eligible for this study

   - Must not have any concurrent condition which in the investigator's opinion makes it
   inappropriate for the patient to participate in the trial or which would jeopardize
   compliance with the protocol

   - Must not have received any investigational agents within 30 days prior to commencing
   study treatment

   - Active thrombophlebitis

   - Pulmonary edema, congestive heart failure or pulmonary embolus


biological: recombinant human hyaluronidase

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts