Expired Study
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Cleveland, Ohio 44195


Purpose:

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 summary:

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.


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


NCT ID:

NCT00022295


Primary Contact:

Study Chair
Graham Kelly, PhD
Marshall Edwards, Inc


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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