Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

February 13, 2017 updated by: Mark Pegram, Stanford University

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

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.

Study Overview

Status

Terminated

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: recombinant human hyaluronidase
Phase 1. 450 units recombinant human hyaluronidase (rHuPH20) administered SC on days 1, 3, 5, and 7 Phase 2: 900 units recombinant human hyaluronidase (rHuPH20) administered SC on days 1 to 21
Given SC
Other Names:
  • rHuPH20
  • Chemophase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related Adverse Events
Time Frame: Up to 1 year
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
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Forearm Volume
Time Frame: Up to 1 year
Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Pegram, Stanford University
  • Principal Investigator: Stanley Rockson, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (ESTIMATE)

August 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-27871
  • P30CA124435 (U.S. NIH Grant/Contract)
  • NCI-2013-01624 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • BRS0032 (OTHER: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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