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

This study has been terminated.
(due to lack of funding)
Sponsor:
Collaborator:
Unicorn Pacific Corporation
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01302366
First received: February 14, 2011
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

TBL12 (the study drug) will be given orally at a dose of 2 units (of 20 mL each) twice a day, in 4 week cycles, until disease progression or until there is sign of disease progression. Each 'unit' is a liquid gel packaged in a 20 mL container sealed with an aluminum lid. All patients will initially receive 2 cycles of therapy (eight weeks), followed by re-staging with urine and/or serum protein assessments. The patient will continue being treated on study if their disease is stable or responding. All patients will then be re-staged four cycles later (end of cycle 6) with protein studies.

TBL12 has been used by a number of patients as a food supplement without any side effects. This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL-12 will help delay the onset of active multiple myeloma, with very few-if any- side effects.


Condition Intervention Phase
Myeloma
Drug: TBL-12
Phase 2

Study Type: Interventional
Study Design: 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 New York University School of Medicine:

Primary Outcome Measures:
  • Percentage of patients who haven't progressed at 1 year of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease.


Secondary Outcome Measures:
  • Percentage of patients who have responded to TBL12 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Response is defined as stable disease, partial response, or complete response after 2 cycles of TBL12.


Enrollment: 20
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sea cucumber extract
TBL12 will be administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4 week cycles.
Drug: TBL-12

TBL12 will be administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4 week cycles.

Each 'unit' is in the formulation of a liquid gel packaged in a 20 mL container sealed with an aluminum lid.


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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01302366

Locations
United States, New York
New York University School of Medicine, Clinical Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Unicorn Pacific Corporation
Investigators
Principal Investigator: Amitabha Mazumder, MD NYU School of Medicine, Clinical Cancer Center
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01302366     History of Changes
Other Study ID Numbers: NYU# 10-02181
Study First Received: February 14, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
multiple myeloma
myeloma
asymptomatic myeloma
smoldering myeloma
Asymptomatic (smoldering) myeloma

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 26, 2014