A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
|ClinicalTrials.gov Identifier: NCT01302366|
Recruitment Status : Terminated (due to lack of funding)
First Posted : February 24, 2011
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: TBL12||Phase 2|
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. The investigators 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma|
|Study Start Date :||February 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Experimental: Sea cucumber extract
TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
- Duration of Response (All Treated Patients) [ Time Frame: up to 3 years ]Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).
- Duration of Response (Excluding Patient Choice and Non-compliance) [ Time Frame: up to 3 years ]Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).
- Percentage of Patients Who Have Responded to TBL12 [ Time Frame: 2 months ]Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302366
|United States, New York|
|New York University School of Medicine, Clinical Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Amitabha Mazumder, MD||NYU School of Medicine, Clinical Cancer Center|