Ipilimumab and Imatinib Mesylate in Advanced Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01738139
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm
  • C-KIT Tyrosine Kinase Protein Overexpression
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Gastrointestinal Stromal Tumor
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Unresectable Melanoma
  • Unresectable Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imatinib Mesylate — DRUG
    Given PO
  • Ipilimumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of ipilimumab and imatinib mesylate in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ipilimumab and imatinib mesylate may work better in treating patients with solid tumors.

Key Dates

Start date
Feb 19, 2013
Status verified
Mar 2024
Primary completion
Dec 13, 2022
Completion
Dec 13, 2023

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ipilimumab, imatinib mesylate)
    Patients receive ipilimumab IV over 90 minutes on day 1 and imatinib mesylate PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 7 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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