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.

Condition	Treatment or Intervention	Phase
adult solid tumor Leukemia Lymphoma small intestine cancer	Drug: XK469  Procedure: chemotherapy	Phase I

Further Study 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.

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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States; Recruiting

Study chairs or principal investigators

Samir D. Undevia, MD,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000069101; UCCRC-11108B; NCI-4570; NCT00028522
Record last reviewed:  August 2004
Last Updated:  December 6, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028522
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08