SNX-5422 to Treat Solid Tumor Cancers and Lymphomas

Completed · Phase 1

Conditions studied: Lymphoma, Neoplasms

In brief

Background: SNX-5422 is an experimental drug that inhibits a protein called Hsp90, which is important for the growth of tumor cells. SNX-5422 has shown some activity against tumors in the laboratory and animal studies. Objectives: To determine the highest safe dose, or maximum tolerated dose (MTD), of SNX-5422 that can safely be given to patients with solid tumor cancers and lymphomas when taken twice a week. To learn how the body's blood and tissue cells react to SNX-5422. To examine the effects of SNX-5422 on tumors and lymphomas. Eligibility: Patients 18 years of age or older who have solid tumor cancers or lymphomas that do not respond to standard therapy or for whom no acceptable standard treatment is available. Design: SNX-5422 is taken by mouth twice a week in 28-day cycles. Treatment may continue as long as the cancer does not worsen and side effects are acceptable. Three to six patients are enrolled in the study at a time. Each group is given a higher dose of SNX-5422 than the previous, as long as the preceding dose was tolerated and until the MTD is determined. When the MTD is found, six more patients are enrolled at that dose level. During the treatment period, patients undergo the following tests and procedures: * Clinic visits for a physical examination each treatment cycle to check on health status. * Blood tests for routine laboratory values, to determine how the body handles SNX-5422, and to examine the effects of SNX-5422 on blood cells and other targets. * Urine tests as needed, depending on the results of blood tests. * CT scans, or other imaging tests every 8 weeks to evaluate the tumor response to treatment. * Tumor biopsy (surgical removal of a tissue sample for examination under a microscope) before the first dose of SNX-5422 and again 24 hours after the first dose to see how the drug affects the tumor. This test is optional.

Key facts

Study ID

NCT00644072

Run by

National Cancer Institute (NCI)

People needed

33

Starts

2008-03-07

Expected to finish

2011-06-16

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients receiving any other investigational agents. Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the principal investigator.
• Uncontrolled medical illness including, but not limited to, ongoing or uncontrolled, symptomatic congestive heart failure (AHA Class II or worse), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients receiving combination antiretroviral therapy are excluded from the study because of possible PK interactions with SNX-5422. HIV positive patients not receiving antiretroviral therapy are excluded due to the possibility that SNX-5422 may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to SNX-5422.
• Chronic diarrhea.
• Gastrointestinal diseases that could affect drug absorption, including postsurgical states such as gastric bypass.
• Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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