Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
Detailed description
OBJECTIVES: * Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol. * Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in this patient population. * Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Interventions
DRUGalvocidib
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable * Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field * No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * No hypercoagulable state other than renal cell cancer Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No prior isolated occurrence of deep venous thrombosis within the past 6 months Pulmonary: * No prior isolated occurrence of pulmonary embolism within the past 6 months Other: * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission * No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I) * No other uncontrolled illness (e.g., diabetes mellitus) * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed * At least 28 days since prior immunotherapy and recovered * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * No prior chemotherapy for renal cell cancer Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 21 days since prior radiotherapy and recovered Surgery: * See Disease Characteristics * Prior resection of primary tumor allowed * At least 28 days since prior surgery and recovered
Countries
United States
Outcome results
None listed