XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
This study is currently recruiting patients.
Sponsored by: |
University of Chicago Cancer Research Center
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Information provided by: |
National Cancer Institute (NCI) |
Purpose
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
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Drug: XK469 Procedure: chemotherapy
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Phase I
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MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Digestive Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of XK469 in Patients With Advanced Solid Tumors or Lymphomas
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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:
Performance status:
Life expectancy:
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:
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
Location
and Contact
Information
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
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000069101; UCCRC-11108B; NCI-4570
Record last reviewed:
August 2004
Record first received:
January 4, 2002
ClinicalTrials.gov Identifier:
NCT00028522Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17