Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of XK469 in patients with advanced solid tumors. - Determine the safety of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine, preliminarily, any anti-tumor activity of this drug in these patients. - Determine the drug metabolism, drug interaction potential, molecular and cellular predictors of efficacy and toxicity, and clinical confirmation of molecular responses in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive XK469 IV over 20 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 15 patients are treated at that dose. Patients in the expanded MTD cohort also receive oral NovaSoy® soybean extract twice daily for the study duration. Patients are followed every 4 weeks. PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-hematological cancer that is unresponsive to available therapies or for which there is no known effective treatment - Measurable or evaluable disease - Clinical or radiological evidence of disease required - No active brain metastases PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal Renal: - Creatinine less than 1.5 mg/dL Cardiovascular: - Ejection fraction at least 50% - No significant arrhythmias - No congestive heart failure Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No dementia or altered mental status - No known HIV infection - No active infection - No other serious uncontrolled medical disorder that would preclude study participation - No known allergies to soy products, rice flour, or gelatin (if receiving study dietary soy supplementation) PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent prophylactic colony-stimulating factors Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - Prior taxanes allowed - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except hormone replacement therapy or medication used to maintain castrate status for patients with progressive hormone-refractory prostate cancer Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow-containing areas - No concurrent radiotherapy Surgery: - Not specified Other: - At least 4 weeks since prior investigational agents - No other concurrent experimental anticancer therapy


NCT ID:

NCT00028548


Primary Contact:

Study Chair
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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