XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

RATIONALE: Drugs used in chemotherapy use 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.Condition:- adult solid tumor- Leukemia- Lymphoma- small intestine cancer Study Type: InterventionalStudy Design: Treatment Official Title: Phase I Study of XK469 in Patients With Advanced Solid Tumors or LymphomasFurther Study Details: OBJECTIVES:Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting toxicity of XK469 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 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. PROJECTED ACCRUAL: Approximately 10-37 patients will be accrued for this study within 4-18.5 months. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both 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 [1] Mark J. Ratain, MD, Study Chair, University of Chicago Cancer Research Center