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Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Providence Health & Services
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT02117362
First received: April 14, 2014
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.


Condition Intervention Phase
Metastatic Melanoma
Biological: GR-MD-02
Biological: Ipilimumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
    Patients return to clinic 9 times in 85 days, receiving treatment on Days 1, 22, 43, and 65. Patients will have physical exams, blood tests, and toxicity evaluations by a research nurse during this time to identify any protocol-defined dose limiting toxicity.


Secondary Outcome Measures:
  • Response rate to combined therapy [ Time Frame: 85 Days ] [ Designated as safety issue: No ]
    Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.


Estimated Enrollment: 22
Study Start Date: March 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Biological: GR-MD-02
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
  • galectin-3 inhibitor
  • galactoarabino-rhamnogalacturonate
Biological: Ipilimumab
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
  • Yervoy
  • Anti-CTLA 4
Experimental: Cohort 2
2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Biological: GR-MD-02
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
  • galectin-3 inhibitor
  • galactoarabino-rhamnogalacturonate
Biological: Ipilimumab
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
  • Yervoy
  • Anti-CTLA 4
Experimental: Cohort 3
4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Biological: GR-MD-02
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
Other Names:
  • galectin-3 inhibitor
  • galactoarabino-rhamnogalacturonate
Biological: Ipilimumab
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
  • Yervoy
  • Anti-CTLA 4
Experimental: Cohort 4
8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Biological: GR-MD-02
8 mg/mg GR-MD-02
Other Names:
  • galectin-3 inhibitor
  • galactoarabino-rhamnogalacturonate
Biological: Ipilimumab
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
  • Yervoy
  • Anti-CTLA 4

Detailed Description:

This study will employ a 3+3 phase I design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.
  • ECOG performance status of 0-1.
  • Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
  • No active bleeding.
  • Anticipated lifespan greater than 12 weeks.
  • Patients must sign a study-specific consent document.

Exclusion Criteria:

  • Patients who have previously received a galectin antagonist
  • Prior ipilimumab to treat metastatic melanoma (prior ipilimumab in the adjuvant setting is permitted if the patient did not experience ≥ grade 3 toxicity related to immunotherapy.
  • Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
  • Patients with history of colitis
  • Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
  • Other active metastatic cancer requiring treatment.
  • Patients with active infection requiring antibiotics.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  • Laboratory exclusions (to be performed within 28 days of enrollment):
  • Need for chronic steroids. Inhaled corticosteroids are acceptable.
  • Inability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
  • Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02117362

Contacts
Contact: Christopher Fountain, RN (503) 215-2691 christopher.fountain@providence.org
Contact: Brenda Fisher, RN (503) 215-2613 brenda.fisher@providence.org

Locations
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Principal Investigator: Brendan Curti, MD         
Sub-Investigator: Todd Crocenzi, MD         
Sub-Investigator: Alison Conlin, MD         
Sub-Investigator: John Godwin, MD         
Sub-Investigator: Rachel Sanborn, MD         
Sub-Investigator: Walter J. Urba, MD, PhD         
Sub-Investigator: William Redmond, PhD         
Sub-Investigator: Keith Bahjat, PhD         
Sub-Investigator: Rui Li, MD, PhD         
Sub-Investigator: Rom Leidner, MD         
Sponsors and Collaborators
Providence Health & Services
Providence Cancer Center, Earle A. Chiles Research Institute
Galectin Therapeutics Inc.
Investigators
Principal Investigator: Brendan Curti, MD Providence Health & Services
  More Information

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02117362     History of Changes
Other Study ID Numbers: 14-004A
Study First Received: April 14, 2014
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Providence Health & Services:
Melanoma
Ipilimumab
Yervoy
Galectin
GR-MD-02
galactoarabino-rhamnogalacturonate
galectin-3 inhibitor
Providence Health & Services
Earle A. Chiles Research Institute
Robert W. Franz Cancer Center

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2014