University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 4K-05-1

Phase I/II Trial of Bortezomib and Bevacizumab (“BB-mib-mab”) in Patients with Advanced or Recurrent Renal Cell Cancer (RCC) with Assessment of Tissue Correlates of Response.

Type: Treatment
Phase: Phase I/II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Anti-Angiogenesis
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  David Quinn, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Ernesto Duverger, D.M., Elysse Faye Ballon, Coordinator

Staff may log in to see study documents.

You may participate in this study if:
1Distant metastatic (Tx Nx M1) or locally recurrent renal cell carcinoma not amenable to cure by surgical or other means.
2Measurable or non-measurable (evaluable) disease either on imaging scan or PE.
3Pathological confirmation of the diagnosis of renal cell carcinoma either at prior nephrectomy or by biopsy of a primary or metastatic lesion – provision of a paraffin-embedded tissue block to confirm the diagnosis and allow molecular correlate assessment is required.
4ECOG PS 0 or 1.
5AGC = / >1.5; platelets = / >100,000 (obtained within 28 days of registration).
6Calculated or measured CrCl at least 40 ml/min (obtained within 28 days of registration).
7Urine protein:creatinine ratio <1.0 at screening.
8May have been treated with interleukin and/or interferon but must not have had >1 line of prior cytotoxic chemotherapy.
9May have had up to 1 biologic therapy provided thay have not had bortezomib or bevacizumab.
10May have had up to 2 prior vaccine therapies.
11May have been treated with RT provided there are measurable or evaluable lesions outside of RT field and has recovered from the side effects of the therapy (typically 2 weeks after final fraction) and <30% of the total BM has been irradiated.
12Signed informed consent (including HIPAA authorization).

You may not participate in this study if:
1Brain metastases or history of brain metastases.
2History of DVT or thromboembolic disease within 1 year or requiring ongoing anti-coagulant therapy.
3History of stroke or MI within 6 months.
4Other major illnesses likely to limit survival, including poorly controlled HTN (BP >150/100 mmHg) or symptomatic or clinically significant PVD or angina pectoris.
5Unstable angina.
6NYHA Gr II or greater CHF.
7Evidence of bleeding diathesis or coagulopathy.
8Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study.
9Minor surgical procedures, FNA, or core biopsies within 7 days prior to day 0.
10Pregnant or breastfeeding women. Female patients of childbearing potential must have a negative serum ß-HCG pregnancy test during screening. Female patients must either be post-menopausal or surgically sterilized or be willing to use an acceptable method of birth control, i.e., hormonal contraceptive, IUD, diaphragm with spermicide, condom with spermicide, or abstinence, for the duration of the study. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Male patients must agree to use an acceptable method for contraception for the duration of the study.
11Inability to comply with study and/or follow-up procedures.
12History of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to day 0.
13Serious, non-healing wound, ulcer, or bone fracture.
14Neuropathy at baseline >Gr 1.
15Prior other investigational drugs within 14 days before enrollment.
16Hypersensitivity to bevacizumab, bortezomib, boron, or mannitol.

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.