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Home > "X" Clinical Trials Conditions > XK469 in Treating Patients With Advanced Solid Tumors  XK469 in Treating Patients With Advanced Solid Tumors
XK469 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatriciaLoRusso, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Patricia LoRusso 313-745-8860
Additional Information:
Study ID Numbers: CDR0000069103; NCI-4550,WSU-C-2346,WSU-T-2001
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028548
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
2. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
3. Combination Chemotherapy in Treating Patients With Solid Tumors
4. Buspirone in Reducing Shortness of Breath in Patients With Cancer
5. R115777 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
XK469 in Treating Patients With Advanced Solid Tumors
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