Phenoxodiol in Treating Patients With Refractory Solid Tumors

Kazia Therapeutics Limited36 enrolled

Overview

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.

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

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

idronoxilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Data from ClinicalTrials.gov

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