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Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

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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

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 23, 2013
Results First Submitted Date  ICMJE December 13, 2016
Results First Posted Date  ICMJE February 7, 2017
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • Incidence of adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 1 year ]
  • Overall response rate defined as the proportion of patients obtaining >= 20% reduction in excess forearm lymphedema [ Time Frame: Up to 1 year ]
    The proportion of patient obtaining a clinically significant reduction in lymphedema (20% reduction in excess forearm volume) at a 95% confidence interval will be reported.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2016)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • Serum biomarkers [ Time Frame: Up to 1 year ]
  • Plasma concentration of recombinant human hyaluronidase [ Time Frame: Baseline, at 30 minutes, and at 8 hours on days 1 and 7 (Phase I) and days 1, 8, 15 and 21 (phase II) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Lymphedema
  • Malignant Neoplasm
Intervention  ICMJE Biological: recombinant human hyaluronidase
Given SC
Other Names:
  • Chemophase
  • rHuPH20
Study Arms  ICMJE 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
Intervention: Biological: recombinant human hyaluronidase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2013)
23
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928030
Other Study ID Numbers  ICMJE IRB-27871
NCI-2013-01624 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0032 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mark Pegram, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark Pegram Stanford University
Principal Investigator: Stanley Rockson School of Medicine
PRS Account Stanford University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP