Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma
Intervention: All-Trans Retinoic Acid (Drug); Ipilimumab (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s): Martin McCarter, MD, Principal Investigator, Affiliation: University of Colorado, Denver
Overall contact: Martin McCarter, MD, Phone: (720) 724-2728, Email: Martin.Mccarter@ucdenver.edu
Summary
The purpose of this study is to assess the safety and efficacy of combined treatment with
Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
Clinical Details
Official title: Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Adverse EventsMDSC frequency MDSC suppressive function
Secondary outcome: Changes in the frequency of tumor-specific T cell responses
Detailed description:
The successful treatment of melanoma with immune checkpoint inhibitors, such as
anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein
1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid
tumors. Despite these advances, only a portion of patients experience a durable response
suggesting that there is room for improvement via enhanced immunomodulatory approaches.
Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting
complete responses in some melanoma patients, the number of patients that achieve durable
clinical benefit is limited and could be improved by a combined immunomodulatory approach.
The objectives of this study are to assess the safety and efficacy of combined treatment
with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that
combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor
antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor
cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.
Eligibility
Minimum age: 18 Years.
Maximum age: 89 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients over the age of 18 year.
- Patients diagnosed with Stage IV melanoma.
- Patients that are considered candidates for ipilimumab therapy.
- Patients able to understand and willing to sign a written informed consent documents.
- Patients willing to have regular blood draws, one before treatment and four during or
after treatment.
Exclusion Criteria:
- Patients under the age of 18.
- Patients with Stage I, II, or III melanoma.
- Patients that have received systemic treatments within four weeks prior to the
beginning of treatment.
- Women that are pregnant or nursing.
- Patients with ocular melanoma.
- Patients taking immunosuppressive medications.
- Patients with active autoimmune disease.
- Patients with known sensitivity to retinoic acid derivatives.
Locations and Contacts
Martin McCarter, MD, Phone: (720) 724-2728, Email: Martin.Mccarter@ucdenver.edu Additional Information
Starting date: March 2015
Last updated: March 25, 2015
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