A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Myeloma Clinical Trial

Official title:

A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01302366
• Other study ID #: NYU# 10-02181
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2011
• Last updated: February 11, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active multiple myeloma, with very few-if any- side effects.

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of multiple myeloma based on standard criteria as follows:

Major Criteria

• Plasmacytomas on tissue biopsy

• Bone marrow plasmacytosis (> 30% plasma cells)

• Monoclonal immunoglobulin (Ig) spike on serum electrophoresis (IgG > 3.5 g/dL or IgA > 2.0 g/dL); kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis

Minor Criteria

• Bone marrow plasmacytosis (10 to 30% plasma cells)

• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria

• Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:

• Any two of the major criteria

• Major criterion 1 plus minor criterion b, c

• Major criterion 3 plus minor criterion a or c

• Minor criteria a, b and c

• Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of = 1 g/dL and/or urine monoclonal immunoglobulin spike of = 200 mg/24 hours.

• Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.

• Has asymptomatic disease, i.e., does not have hypercalcemia, renal insufficiency, anemia or bone lesions.

• Karnofsky performance status = 80 (See Appendix B)

• Is infertile (i.e. surgically sterile or 12 months post-menopausal) or is practicing an adequate form of contraception, as judged by the investigator (i.e., birth control pills, double barrier method, abstinence, etc.)

• Age 18 years or older

• Has given voluntary written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

• Prior treatment for myeloma (symptomatic or asymptomatic).

• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)

• Plasma cell leukemia

• Patients with a history of thyroid problems.

• Receiving steroids > the equivalent of 10 mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis

• Infection not controlled by antibiotics

• Human Immunodeficiency Virus (HIV) infection. Patients should provide consent for HIV testing according to the institution's standard practice

• Known active hepatitis B or C

• New York Hospital Association (NYHA) Class III or IV heart failure or EKG evidence of acute ischemic disease

• Second malignancy requiring treatment in last 3 years

• Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

• Positive pregnancy test in women of childbearing potential

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• TBL12

Locations

Country	Name	City	State
United States	New York University School of Medicine, Clinical Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Unicorn Pacific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bladé J, Samson D, Reece D, Apperley J, Björkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Response (All Treated Patients)	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).	up to 3 years	No
Primary	Duration of Response (Excluding Patient Choice and Non-compliance)	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).	up to 3 years	No
Secondary	Percentage of Patients Who Have Responded to TBL12	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)	2 months	No