NCT00025376

PS-341 in Treating Patients With Metastatic Kidney Cancer

Official Title:

A Phase II Trial of PS-341 in Patients With Renal Cell Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic renal cell cancer
* Measurable disease

* At least 2.0 cm in at least 1 dimension by physical exam OR at least 1.0 cm in at least 1 dimension by radiologic exam
* Single measurable lesion must not be within prior radiotherapy portal
* Tumor lesion amenable to core biopsy

* At least 1 cm of tumor obtainable
* No active CNS metastatic disease

* Single previously resected CNS metastasis allowed provided no disease progression 8 weeks after therapy and no longer requiring steroids or antiseizure medications

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

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 no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other:

* No other uncontrolled concurrent illness
* 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 barrier-method contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior immunotherapy or biotherapy allowed

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis)

Surgery:

* See Disease Characteristics

Other:

* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients

Disease(s) and\or Condition(s)

Kidney Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: PS-341
    • Description:
    • Arm Group Labels: PS-341 administration followed by biopsy, Pre-Treatment biopsy followed by PS-341 administration
    • Type: PROCEDURE
    • Name: Tumor Biopsy
    • Description:
    • Arm Group Labels: PS-341 administration followed by biopsy, Pre-Treatment biopsy followed by PS-341 administration
Sponsor
  • University of Chicago