Dasatinib and Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumors or Other Sarcomas That Cannot Be Removed by Surgery or Are Metastatic

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01643278
Phase
PHASE1
Status
Completed

Conditions

  • Gastrointestinal Stromal Tumor
  • Stage III Soft Tissue Sarcoma
  • Stage IV Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Dasatinib — DRUG
    Given PO
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of dasatinib when given together with ipilimumab in treating patients with gastrointestinal stromal tumors or other sarcomas that cannot be removed by surgery or have spread to other places in the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways by targeting certain cells. Giving dasatinib together with ipilimumab may be a better treatment for patients with gastrointestinal stromal tumors or other sarcomas.

Key Dates

Start date
Jul 31, 2012
Status verified
Jan 2017
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

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

Arms

  • Experimental: Treatment (dasatinib and ipilimumab)
    Patients receive dasatinib PO QD for 7 days. Patients then receive dasatinib PO QD and ipilimumab IV once on weeks 1, 4, 7 and 10. Beginning on week 24, patients then receive dasatinib PO QD and ipilimumab IV once every 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose defined as the highest dose studied for which the observed incidence of dose-limiting toxicity is less than 33% according to the National Cancer Institute Common Toxicity Criteria [ Time Frame: Up to week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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