Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01096810
• Other study ID #: TBL 12
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2010
• Last updated: September 8, 2014
• Start date: September 2008
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Jagannath, Sundar, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Purpose:

The purpose of this study is to see if the food supplement, TBL 12, which is a blend of Sea Cucumber, Sea Sponge, Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are.

Eligibility:

Several criteria must be met to be eligible for this study, including but not limited to the following:

• a diagnosis of asymptomatic multiple myeloma

• adequate cardiac, liver and kidney function

• age 18 and older

Description:

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 for one year 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of multiple myeloma

• Measurable disease

• For non-secretors, measurable protein by Freelite or plasmacytoma

• Asymptomatic disease

Exclusion Criteria:

• POEMS syndrome

• Plasma cell leukemia

• Receiving steroids greater than the equivalent of 10 mg prednisone

• Infection not controlled by antibiotics

• HIV infection

• Known active hepatitis B or C

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• TBL 12
TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Jagannath, Sundar, M.D.	Unicorn Pacific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression to symptomatic disease (CRAB symptoms)	To determine the response rate and time to progression of asymptomatic multiple myeloma patients receiving TBL 12.		No
Secondary	Antitumor effect	To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis		No