Clinical trial · Interventional
Bortezomib in Treating Patients With Metastatic Kidney Cancer
A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients
NCT00276614CI-TRIAL-00046880completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Velcade
- description
- Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed pure non-clear cell renal cell carcinoma (RCC) * Distant metastatic disease (Tx, Nx, M1) * Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein * Measurable disease on imaging scan (≥ 1 cm) * Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy. * Life expectancy ≥ 3 months * Karnofsky performance status ≥ 60% * Negative pregnancy test * Fertile patients must use an acceptable method of contraception * No other major illnesses likely to limit survival * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1, 000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL * ALT or AST ≤ 2.5 times upper limit of normal * At least 4 weeks since prior radiotherapy and recovered * More than 30 days since any other prior investigational drugs Exclusion Criteria: * active CNS metastases * pregnant or nursing * myocardial infarction within the past 6 months * New York Heart Association class III or IV heart failure * uncontrolled angina * severe uncontrolled ventricular arrhythmias * electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Peripheral neuropathy ≤ grade 1 * hypersensitivity to bortezomib, boron, or mannitol * history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin * serious medical or psychiatric illness that would preclude study participation * prior cytotoxic chemotherapy for this cancer * other concurrent investigational therapy * concurrent chemotherapy, immunotherapy, or hormonal therapy
References
Publications (0)
Data not yet available
No reference posted for this study.