Phenoxodiol in Treating Patients With Refractory Solid Tumors

NCT ID: NCT00022295

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2007-10-31

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.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
• Determine the steady-state pharmacokinetics of this drug in these patients.
• Determine the tumor response in patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

idronoxil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kazia Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Principal Investigators

Graham Kelly, PhD

Role: STUDY_CHAIR

MEI Pharma, Inc.

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NOVOGEN-NV06-0024

Identifier Type: -

Identifier Source: secondary_id

CCF-4269

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1663

Identifier Type: -

Identifier Source: secondary_id

CDR0000068802

Identifier Type: -

Identifier Source: org_study_id