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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592579
First Posted: January 14, 2008
Last Update Posted: February 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CASI Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
Relapsed Multiple Myeloma Plateau Phase Multiple Myeloma Drug: 2-methoxyestradiol Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma [ Time Frame: At least yearly ]

Secondary Outcome Measures:
  • 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 [ Time Frame: As reported ]
  • To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma [ Time Frame: At least yearly ]

Enrollment: 60
Study Start Date: March 2001
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Panzem

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  6. Have life expectancy of at least 3 months
  7. Have ECOG performance status of 0, 1, or 2
  8. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
  9. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592579


Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
  More Information

Publications:
Responsible Party: Carolyn Sidor, MD, MBA; Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00592579     History of Changes
Other Study ID Numbers: ME-CL-004
First Submitted: December 28, 2007
First Posted: January 14, 2008
Last Update Posted: February 26, 2009
Last Verified: February 2009

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
2-methoxyestradiol
Estradiol
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs