Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02192541
Phase
PHASE1
Status
Terminated

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Ziv-Aflibercept — DRUG
    Ziv-aflibercept is a soluble fusion protein with high binding affinity for vascular endothelial growth factor A (VEGF-A), vascular endothelial growth factor B (VEGF-B), and placenta growth factor (PIGF) and thus confers anti-angiogenic activity
  • Ganetespib — DRUG
    Ganetespib is a non-geldamycin synthetic inhibitor of Hsp90 with activity against multiple cancer cell lines and tumor xenografts in preclinical models.

Study Details

Background: \- Some people have cancers that don't respond to standard treatments. In these cases, doctors may try to use drugs to slow the growth of the cancer. Objectives: \- To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept. Eligibility: \- Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and sarcomas. Design: * Participants will be screened with medical history, blood tests, and scans to measure their tumors. * Participants will have one or two eye exams, with dilating eye drops. * Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib will be given once a week on the same day for 3 weeks in a row, followed by a 1-week rest period. Ziv-aflibercept will be given once every other week. The drugs will be given in 28-day cycles. * Participants may have a small piece of their tumor collected once or twice. This is done using a small needle during computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound scan. * Participants will have their blood pressure checked at each visit. They will check it at home every day of the study. * Participants may have one or more whole-body positron emission tomography (PET) scans with 89Zr-panitumumab. A small amount of a radioactive chemical will be injected through a tube in an arm. Participants will lie on a bed that slides in and out of the donut-shaped PET scanner. They will have small amounts of blood drawn. * Participants may stay in the study as long as they are tolerating the drugs and their tumor is not getting worse.

Key Dates

Start date
Dec 2, 2014
Status verified
Mar 2018
Primary completion
Feb 25, 2016
Completion
Feb 25, 2016

Study Design

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

Arms

  • Experimental: Ganetespib and Ziv-Aflibercept
    Ganetespib was administered intravenously, over 1 hour, weekly, on days 1, 8, and 15 of each 28-day cycle. Ziv-aflibercept was administered intravenously, over 1 hour, every 2 weeks, on days 1 and 15 of each 28-day cycle. Ganetespib was started at a dose level of 100 mg/m\^2 + ziv-aflibercept at 3 mg/kg or 4 mg/kg.

Primary Outcome Measure

Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 [ Time Frame: Date treatment consent signed to date off study, approximately 12 months and 44 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

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National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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