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

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ClinicalTrials.gov Identifier: NCT02117362
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Providence Health & Services

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Melanoma Biological: 1 mg/kg GR-MD-02 Biological: 2 mg/kg GR-MD-02 Biological: 4 mg/kg GR-MD-02 Biological: 8 mg/kg GR-MD-02 Biological: Ipilimumab Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
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: 1 mg/kg 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: 2 mg/kg 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: 4 mg/kg 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: 8 mg/kg 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




Primary Outcome Measures :
  1. Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) [ Time Frame: 21 Days ]
    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 :
  1. Response rate to combined therapy [ Time Frame: 85 Days ]
    Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic or unresectable melanoma for whom treatment with ipilimumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
  • Patients must be ≥ 18 years of age.
  • Eastern Collaborative Oncology Group (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.

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): NCT02117362


Locations
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
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

Additional Information:
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02117362     History of Changes
Other Study ID Numbers: 14-004A
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs