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

This study has been terminated.
(The research is permanently closed to enrollment.)
Sponsor:
Collaborator:
Unicorn Pacific Corporation
Information provided by (Responsible Party):
Jagannath, Sundar, M.D.
ClinicalTrials.gov Identifier:
NCT01096810
First received: February 22, 2010
Last updated: June 14, 2016
Last verified: June 2016
  Purpose

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

Condition Intervention Phase
Multiple Myeloma
Drug: TBL 12
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Resource links provided by NLM:


Further study details as provided by Jagannath, Sundar, M.D.:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: From date of treatment until the date of first documented progression ] [ Designated as safety issue: No ]

    To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).

    Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).


  • Response Rate [ Time Frame: from date of start of treatment until the date of best documented response up to date of progression ] [ Designated as safety issue: No ]

    The response rate - percentage of participants with overall response.

    Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate.



Secondary Outcome Measures:
  • Antitumor Effect [ Time Frame: Antitumor effect ] [ Designated as safety issue: No ]
    To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis


Enrollment: 20
Study Start Date: September 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TBL 12
TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Drug: TBL 12
TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.
Other Name: Sea Cucumber

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096810

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Jagannath, Sundar, M.D.
Unicorn Pacific Corporation
Investigators
Principal Investigator: Sundar Jagannath, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Jagannath, Sundar, M.D.
ClinicalTrials.gov Identifier: NCT01096810     History of Changes
Other Study ID Numbers: TBL 12 
Study First Received: February 22, 2010
Results First Received: March 24, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Jagannath, Sundar, M.D.:
Asymptomatic

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2016