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Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928030
Recruitment Status : Terminated (Low accrual)
First Posted : August 23, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mark Pegram, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphedema Malignant Neoplasm Biological: recombinant human hyaluronidase Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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
Biological: recombinant human hyaluronidase
Given SC
Other Names:
  • Chemophase
  • rHuPH20




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928030


Locations
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United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark Pegram Stanford University
Principal Investigator: Stanley Rockson School of Medicine
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Responsible Party: Mark Pegram, Susy Yuan-Huey Hung Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01928030    
Other Study ID Numbers: IRB-27871
NCI-2013-01624 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0032 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2013    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: March 21, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasms
Lymphedema
Lymphatic Diseases