A Molecular Pharmacodynamic Dose-titration Trial of Conjugated Linoleic Acid (CLA; Clarinol®) in Patients With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Conjugated Linoleic Acid

• Registration Number: NCT00951158
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

It has become apparent that many cancers depend on specific fats (lipids) for their continued growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary supplement that promotes weight loss and loss of fat. CLA was recently shown to block the metabolism (uptake and production) of lipids required for growth of some cancers, resulting in killing of cancer cells. The investigators will conduct a clinical trial to test whether oral CLA blocks metabolism of lipids in patients with advanced cancers. Since the dose of CLA that may do this is not yet known, the investigators will start at a dose of CLA known to be tolerable and effective for weight loss. If this dose does not block lipid metabolism, the investigators will test higher doses in successive groups of patients until the investigators identify an effective dose, unless the investigators find that these higher doses cannot be tolerated. In order to verify that CLA is absorbed, it is necessary to measure CLA levels in blood before and after doses are given. Likewise, in order to verify that CLA blocks lipid metabolism, the investigators will need to obtain small samples of abdominal fat (and, in some patients, samples of tumors).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Study Start: 2010-03
• Status Verified: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLA	Conjugated Linoleic Acid	Open-label dose-titration trial of CLA in patients with advanced, refractory malignancies. oral dose 7.5 g/day 28 day cycle

Primary Outcome Measures

Name	Time	Method
To define a tolerable dose of oral CLA, given on a daily schedule, that maximally inhibits S14 expression in adipocytes of patients with advanced solid tumors.	2 years

Secondary Outcome Measures

Name	Time	Method
To document ant tumor activity of CLA, if observed, in this population.	2 years
To define the plasma pharmacokinetics of CLA in patients with advanced cancer.	2 years
To obtain data on the safety and tolerability of CLA given orally, on a daily schedule to patients with advanced cancer.	2 years
To quantify the effects of CLA on S14 expression in tumor tissue, at its recommended phase II dose	2 years
To quantify effects of CLA on expression of lipogenic enzymes regulated by S14, lipoprotein lipase, and phospho-akt in adipocytes (and tumor tissue).	2 years
To quantify effects of CLA on expression of biomarkers for cellular proliferation, S/G2 phases of cell cycle, and apoptosis in tumor tissue.	2 years

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States