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Home > "X" Clinical Trials Conditions > XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma  XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
For Condition: Leukemia,small intestine cancer,adult solid tumor,Lymphoma
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer 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 or lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting toxicity of XK469 in two different dosing schedules in patients with advanced solid tumors or lymphomas. - Determine the safety of this drug in these patients. - Determine the tolerance to this drug in these patients. - Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. - Determine the presence of genetic variations that may affect metabolism and disposition of this drug in these patients. - Determine, preliminarily, any antineoplastic activity of this drug in these patients. OUTLINE: This is a dose-escalation study. - Patients receive XK469 IV over 30 minutes on days 1, 3, and 5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of XK469 until the recommended phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the recommended phase II dose (for a maximum of 20 patients treated at that dose). - Once the recommended phase II dose is determined on schedule A, additional patients are accrued and receive escalating doses of XK469 IV over 30 minutes on day 1, beginning at a reduced dose. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Dose escalation continues as in schedule A. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4-18.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists - No active brain metastases - Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal (unless due to documented Gilbert's syndrome) Renal: - Creatinine less than 1.5 times upper limit of normal Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent uncontrolled illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen) PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent palliative radiotherapy Surgery: - Not specified Other: - See Disease Characteristics - Recovered from all prior therapy - No other concurrent investigational agents - No concurrent commercial agents or therapies directed at malignancy - No concurrent combination anti-retroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkRatain, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Mark Ratain 773-702-4400
Additional Information:
Study ID Numbers: CDR0000069101; NCI-4570,UCCRC-NCI-4570
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028522
Other Small Intestine Cancer Studies:
1. Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
2. CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
3. Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
4. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
5. Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
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XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
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