Phenoxodiol in Treating Patients With Refractory Solid Tumors

• ClinicalTrials.gov Identifier: NCT00022295
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: March 26, 2013
• Sponsor: Kazia Therapeutics Limited
• Information provided by: National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: idronoxil	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: August 2001
• Actual Study Completion Date: October 2007

Arms and Interventions

Outcome Measures

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Kazia Therapeutics Limited

Investigators

• Study Chair: Graham Kelly, PhD; MEI Pharma, Inc.

More Information

• ClinicalTrials.gov Identifier: NCT00022295
• Other Study ID Numbers: CDR0000068802; NOVOGEN-NV06-0024; CCF-4269; NCI-V01-1663
• First Posted: January 27, 2003
• Last Update Posted: March 26, 2013
• Last Verified: March 2007

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms