Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

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.

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.

Eligibility 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