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Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma

The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses,
but associated with higher frequency of toxicities. IL-2 given at lower doses have
demonstrated similar results than higher doses but it requires further study. RCC is highly
vascular and expresses high levels of VEGF. Bevacizumab is a monoclonal antibody directed
against the Vascular Endothelial Growth Factor (VEGF) responsible for angiogenesis.

The study is designed to evaluate a response defined as time to progression, safety and
toxicity in patients with metastatic renal cell carcinoma. Tissue correlation to evaluate
the impact of vascular VEGF on clinical outcome will be retrospectively performed

Inclusion Criteria:

- Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell

- Evidence of measurable metastatic disease, no progression diseases or the patient's
condition will not need radiotherapy in the next 4 weeks.

- Previous definitive radiotherapy to 1 metastatic site is acceptable

- At least 4 weeks have elapsed since radiation therapy

- Patients must be free of serious co-morbidity and have a life expectancy of ≥24 weeks

- Patients should have adequate physiologic reserves as evidence of adequate
performance status, blood parameters, hepatic and kidney function, no evidence of
active cardiac diseases and showing an acceptable function and adequate coagulation

Exclusion Criteria:

- History of central nervous System metastases

- Known HIV positive

- Recent history of brain's vascular disease within 6 months; patients requiring
regular antianginal therapy (coronary disease) or insufficient circulation in lower
extremities are not eligible

- Active autoimmune disease

- Patients who have had steroid therapy in the past three weeks

- Patients taking concurrent anticancer drugs

- Biphosphonates (Zometa) are not allowed, unless started 4 weeks prior to
participation in the study

- Female patients pregnant or breast-feeding

- The patient has an unstable medical condition, such as uncontrolled Diabetes mellitus
or Hypertension; active infections requiring systemic antibiotics, antivirals, or
antifungal; clinical evidence of cardiac or pulmonary dysfunction including,
uncontrolled arrhythmias, unstable coagulation disorders; or recent myocardial
infarction (within 6 months)

- Any condition including abnormal laboratory results, that in the opinion of the
investigator places the patient at an unacceptable risk if he/she participate in the

- Prior malignancy (within the last 3 years), except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer or other cancer for which the
patient has been - free for at least 3 years

- Uncontrolled Blood pressure > 150/100

- Major 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

- Minor surgery 7 days before day 0

- Serious, non healing wound, ulcer, or bone fracture; and,inability to accomplish the

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Principal Investigator

Robert J. Amato, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

November 2007

Related Keywords:

  • Carcinoma, Renal Cell
  • kidney cancer
  • M3thodist
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



The Methodist Hospital Research Institute Houston, Texas  77030