Phenoxodiol in Treating Patients With Refractory Solid Tumors

Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: idronoxil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Kazia Therapeutics Limited
• Investigators: Study Chair: Graham Kelly, PhD, MEI Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: August 10, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CDR0000068802; NOVOGEN-NV06-0024; CCF-4269; NCI-V01-1663