NCT00028821

Brief Summary

Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

4.2 years

First QC Date

January 4, 2002

Last Update Submit

January 15, 2013

Conditions

Refractory Multiple MyelomaStage III Multiple MyelomaUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0

    Presented primarily in a descriptive fashion.

    28 days

  • Number of toxicity incidents as assessed by CTC version 2.0

    Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

    Up to 3 months after completion of treatment

Secondary Outcomes (3)

  • Biologic activity rate (BAR)

    At day 1 and at day 28

  • Angiogenesis inhibition via an ex vivo angiogenesis assay

    At day 1 and at day 28

  • Number of responses

    Up to 3 months after completion of treatment

Study Arms (1)

Treatment (2-methoxyestradiol)

EXPERIMENTAL

Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: 2-methoxyestradiolOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

2-methoxyestradiolDRUG

Given orally

Also known as: 2-ME, 2-Methoxy Estradiol, 2ME2, Panzem
Treatment (2-methoxyestradiol)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (2-methoxyestradiol)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (2-methoxyestradiol)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed solid tumor that is clinically unresectable
  • No known standard therapy that is potentially curative or definitely capable of extending life expectancy
  • Patients with multiple myeloma may be enrolled to expansion cohort once the recommended phase II dose is established
  • Tumor amenable to serial biopsy
  • No bone metastases as only site of disease
  • No CNS metastases
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10.0 g/dL
  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal (ULN)
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

2-MethoxyestradiolMercaptoethanol

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEthanolAlcoholsOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Study Officials

  • Charles Erlichman

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

April 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)