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A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

Sponsor
CASI Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00592579
Collaborator
(none)
60
Enrollment
2
Locations
1
Arm
90.1
Duration (Months)
30
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
Study Start Date :
Mar 1, 2001
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Open label, oral administration of 2ME2

Drug: 2-methoxyestradiol
800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
Other Names:
  • Panzem

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma [At least yearly]

    Secondary Outcome Measures

    1. To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma [As reported]

    2. To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma [At least yearly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.

    2. Be at least 18 years of age.

    3. Have monoclonal plasma cells in the marrow.

    4. have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.

    5. Have laboratory data as specified below:

    • AST and ALT < 2.5 x upper limit of normal (ULN)

    • Alk phos < 5.0 x ULN

    • direct bilirubin < 2 x ULN

    • Creatinine < 3.0 x ULN

    • ANC greater than or equal to 750 cells/mm3

    • Platelets > 25,000/mm3

    • Hemoglobin greater than or equal to 7.0g/dL

    1. Have life expectancy of at least 3 months

    2. Have ECOG performance status of 0, 1, or 2

    3. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.

    4. Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.

    Exclusion Criteria:

    1. Be pregnant or nursing.

    2. Have any condition that is likely to detrimentally affect regular follow up.

    3. Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.

    4. Have an active infection

    5. Have had major surgery within 21 days of starting 2ME2 administration

    6. Have additional uncontrolled serious medical or psychiatric illness

    7. have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)

    8. Have uncontrolled or untreated active bleeding or thrombotic disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    2 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • CASI Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00592579
    Other Study ID Numbers:
    • ME-CL-004
    First Posted:
    Jan 14, 2008
    Last Update Posted:
    Feb 26, 2009
    Last Verified:
    Feb 1, 2009
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    2-Methoxyestradiol

    Study Results

    No Results Posted as of Feb 26, 2009