A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma - Full Text View

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:

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: 2-Methoxyestradiol

U.S. FDA Resources

Further study details as provided by EntreMed:

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:

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.
Be at least 18 years of age.
Have monoclonal plasma cells in the marrow.
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.
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
Have life expectancy of at least 3 months
Have ECOG performance status of 0, 1, or 2
Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
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:

Be pregnant or nursing.
Have any condition that is likely to detrimentally affect regular follow up.
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.
Have an active infection
Have had major surgery within 21 days of starting 2ME2 administration
Have additional uncontrolled serious medical or psychiatric illness
have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
Have uncontrolled or untreated active bleeding or thrombotic disorder.

Contacts and Locations

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

EntreMed

More Information

Publications:

Rajkumar SV, Richardson PG, Lacy MQ, Dispenzieri A, Greipp PR, Witzig TE, Schlossman R, Sidor CF, Anderson KC, Gertz MA. Novel therapy with 2-methoxyestradiol for the treatment of relapsed and plateau phase multiple myeloma. Clin Cancer Res. 2007 Oct 15;13(20):6162-7.

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
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013