NCT00022295

Brief Summary

RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2001

Longer than 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

August 1, 2001

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2007

First QC Date

August 10, 2001

Last Update Submit

March 25, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

idronoxilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor * Refractory to standard therapy OR * No standard therapy exists * No breast cancer * No active CNS metastases * Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Platelet count greater than 100,000/mm\^3 * WBC greater than 3,000/mm\^3 * Neutrophil count greater than 1,500/mm\^3 * Hemoglobin greater than 10 g/dL (9 g/dL for women) Hepatic: * Bilirubin less than 1.2 mg/dL * Transaminases no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 1.4 mg/dL Other: * No active infection * No contraindication to the insertion of a vascular access device * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent systemic anticancer immunotherapy Chemotherapy: * No concurrent systemic anticancer chemotherapy Endocrine therapy: * No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists Radiotherapy: * See Disease Characteristics * Concurrent localized radiotherapy for control of local disease complications allowed Surgery: * See Disease Characteristics Other: * Recovered from prior antineoplastic therapy * At least 4 weeks since prior investigational agents * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

phenoxodiol

Study Officials

  • Graham Kelly, PhD

    MEI Pharma, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

August 1, 2001

Study Completion

October 1, 2007

Last Updated

March 26, 2013

Record last verified: 2007-03

Locations

US(1)