ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01675128
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Background: \- Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They want to see if the drugs are a safe and effective treatment for advanced solid tumors or colorectal cancer that has not responded to other treatments. Objectives: \- To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid tumors or colorectal cancer. Eligibility: \- Individuals at least 18 years of age who have solid tumors or colorectal cancer that has not responded to other treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected as well before and after treatment. Imaging studies will also be performed. * Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the first cycle, they will also have ISIS 183750 on days 3 and 5. * Participants will take irinotecan every second week, beginning on day 15 of the first cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment will continue as long as the cancer does not grow and the side effects are not severe.

Key Dates

Start date
Aug 31, 2012
Status verified
Mar 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Level I
    Irinotecan 160 mg/m\^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
  • Experimental: Phase I Dose Level II
    Irinotecan 180 mg/m\^2 every other week; ISIS 183750 1000 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
  • Experimental: Phase II Dose Level I
    Irinotecan 160 mg/m\^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of ISIS 183750 in Advanced Solid Tumors [ Time Frame: 2 years ]

Locations (1)

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

Find similar trials in Bethesda, MD

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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