Clinical trial NCT01096810: Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma
Official title: A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Asymptomatic
Lead sponsor: Jagannath, Sundar, M.D.
Sponsor class: INDIV
Collaborators: name: Unicorn Pacific Corporation
First posted: 2010-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose:

The purpose of this study is to see if 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Progression
timeFrame: From date of treatment until the date of first documented progression
measure: Response Rate
timeFrame: from date of start of treatment until the date of best documented response up to date of progression
Secondary outcomes:
measure: Antitumor Effect
timeFrame: Antitumor effect
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sundar Jagannath, MD
role: PRINCIPAL_INVESTIGATOR
References: