A Phase II Trial of TBL-12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of
Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After
evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of
hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM),
there is no standard therapy. Thalidomide has been tried in patients with ASxM but with
significant toxicity. The patients with ASxM are evaluable in terms of paraprotein
measurements.
TBL12 sea cucumber extract has been shown to have a number of antitumor properties
preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been
used by a number of patients as a food supplement without any toxicity detected. We thus
propose to determine the clinical activity of this agent in patients with ASxM. Patients
will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily until disease
progression and the effects on the paraprotein noted. Clinical effects seen will be
correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The
results of this trial may form the basis for the use of this nontoxic agent in patients with
the prodrome of or with other early cancers.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients who haven't progressed at 1 year of treatment
Assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease.
1 year
No
Amitabha Mazumder, MD
Principal Investigator
NYU School of Medicine, Clinical Cancer Center
United States: Food and Drug Administration
NYU# 10-02181
NCT01302366
February 2011
June 2014
Name | Location |
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New York University School of Medicine, Clinical Cancer Center | New York, New York 10016 |