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

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00592579
First received: December 28, 2007
Last updated: February 25, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: December 28, 2007
Last Updated: February 25, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
2-methoxyestradiol
Estradiol
Antimitotic Agents
Antineoplastic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014