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A Phase II Study of VEGF Blockade With Bevacizumab Combined With Autologous Tumor/Dendritic Cell Vaccine (DC Vaccine), Interleukin-2 (IL-2) and Interferon-α-2b (IFNα-2b) in Patients With Metastatic Renal Cell Carcinoma (RCC)

Phase 2
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

A Phase II Study of VEGF Blockade With Bevacizumab Combined With Autologous Tumor/Dendritic Cell Vaccine (DC Vaccine), Interleukin-2 (IL-2) and Interferon-α-2b (IFNα-2b) in Patients With Metastatic Renal Cell Carcinoma (RCC)

All eligible patients will receive a total of five treatment weeks, each consisting of
approximately 5 days. Prior to therapy, patients will undergo apheresis for DC preparation.
DC-Tumor vaccines will be frozen in 90% pooled human AB serum/ 10% DMSO to be used for
treatment Patients will be dosed with bevacizumab (10mg/kg, Genentech) intravenously every
two weeks beginning four weeks prior to the first vaccine. Each treatment week includes
ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of
continuous intravenous infusion of IL-2 (18 MiU/m2, Novartis), and three subcutaneous
injections of IFNa-2b (6 MiU, Schering -Plough Corp.) (every other day). The first two
treatment weeks, the induction phase, will be separated by a 9 day rest. Three additional
treatment weeks, the maintenance phase, will be separated by 23 rest days.

Inclusion Criteria:

1. Histologically confirmed metastatic renal cell carcinoma with measurable disease.

2. Adequate tumor tissue properly stored and available to produce lysate for a minimum
of three vaccine preparations.

3. Patients must be at least 4 weeks from their last therapy (tyrosine kinase
inhibitors, immunotherapy, radiation, surgery or chemotherapy (6 weeks for
nitrosureas) and recovered from all ill effects.

4. Have measurable disease.

5. Patients must be at least 4 weeks from major surgery, 1 week from minor surgery, and
recovered from all ill effects.

6. Karnofsky Performance Status ≥80%.

7. Adequate end organ function:

8. Women should not be lactating and, if of childbearing age, have a negative pregnancy
test within two weeks of entry to the study.

9. Appropriate contraception in both genders.

10. The patient must be competent and have signed informed consent.

11. Patients may have received one prior therapy with targeted therapies (e.g. sorafenib
and sunitinib).

Exclusion Criteria:

1. Patients who have previously received bevacizumab or IL-2 are not eligible.

2. Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
cancer such as cervical CIS, superficial bladder cancer without local recurrence or
breast CIS.

3. In patients with a prior history of invasive malignancy, less than five years in
complete remission.

4. Positive serology for HIV, hepatitis B or hepatitis C which should be confirmed with

5. Significant co-morbid illness such as uncontrolled diabetes or active infection that
would preclude treatment on this regimen.

6. Use of corticosteroids or other immunosuppression (if patient had been taking
steroids, at least 2 weeks must have passed since the last dose). Inhaled steroids >
1000mcg beclomethasone per day or its equivalent.

7. History of inflammatory bowel disease or other serious autoimmune disease. (Not
including thyroiditis and rheumatoid arthritis).

8. Patients with organ allografts.

9. Uncontrolled hypertension (BP >150/100 mmHg).

10. Proteinuria dipstick > 3+ or > 2gm/24 hours, or a urine protein:creatinine ratio >
1.0 at screening.

11. Major surgery, open biopsy, significant traumatic injury within 28 days of starting
treatment or anticipation of need for major surgical procedure during the course of
the study.

12. Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to starting treatment. Central venous catheter placements are permitted.

13. History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess
within 6 months prior to starting treatment.

14. Serious, non-healing wound, ulcer, or bone fracture.

15. History of tumor-related or other serious hemorrhage, bleeding diathesis, or
underlying coagulopathy.

16. History of deep venous thrombosis, or other thrombotic event within the past six
months or clinically significant peripheral vascular disease.

17. Inability to comply with study and/or follow-up procedures.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective clinical response rate and progression free survival (PFS) to this combined treatment regimen.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Marc S Ernstoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

January 2016

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756