CompletedPhase 1

TKM 080301 for Primary or Secondary Liver Cancer

United States1 participantsStarted 2011-08-26

Plain-language summary

Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink. Objectives: \- To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have inoperable cancer that has started in or spread to the liver. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests, and imaging studies. * Participants will have a liver angiogram (type of X-ray study) to look at the blood flow in the liver and to place a catheter for delivery of the TKM080301. * Participants will have a single dose of TKM-080301 given directly into the liver. After the drug has been given, the catheter will be removed. They will have frequent blood tests and keep a diary to record side effects. * Participants may have two more doses, each dose given 2 weeks apart. {Before each dose, participants will have another angiogram and catheter placement.}They may also have liver biopsies to study the tumors. * Two weeks after the third treatment (one full course), participants will have a physical exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to three more courses of the study drug. * Participants will have follow up visits every 3 months for 2 years after the last course and then every 6 months as required.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed colorectal, pancreas, gastric, breast, ovarian and esophageal cancers with hepatic metastases, or primary liver cancers (Hepatocellular carcinoma and Cholangiocarcinoma).
✓. Hepatic disease must be measurable per RECIST Criteria (version 1.1).
✓. Hepatic disease should be deemed unresectable as per standard of care criteria.
✓. All patients must have failed to respond to standard regimens or therapies known to provide clinical benefit. For example:
✓. Greater than or equal to 18 years of age
✓. Must be able to understand and sign the Informed Consent Document
✓. Clinical performance status of ECOG less than or equal to 2
✓. Life expectancy of greater/equal than two months

Exclusion criteria

✕. Any known brain metastases (prior or current regardless of treatment status)

What they're measuring

To evaluate feasibility of administering TKM-080301 via HAI, and establish MTD and DLT.

Timeframe: 2 years

Trial details

NCT IDNCT01437007

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-06-21

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