Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00440973

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy is safer and less toxic than the standard treatment for renal cell carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Bevacizumab Drug: Interleukin-2	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: treatment arm PI relocated, currently data is no longer available	Drug: Bevacizumab monoclonal antibody with anti-angiogenesis properties used as chemotherapy Other Names: Avastin Drug: Interleukin-2 immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T & B lymphocyte proliferation Other Names: IL-2

Arm

Intervention/Treatment

Other: treatment arm

PI relocated, currently data is no longer available

Drug: Bevacizumab

monoclonal antibody with anti-angiogenesis properties used as chemotherapy

Other Names:

Avastin

Drug: Interleukin-2

immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T & B lymphocyte proliferation

Other Names:

IL-2

Outcome Measures

Primary Outcome Measures

time to progression [During study (currently data no longer available)]
currently data no longer available

Secondary Outcome Measures

Collect data on tumor responses produced by interleukin-2 and Bevacizumab [During study (currently data no longer available)]
currently data no longer available
Evaluate safety and toxicity of the combination of interleukin-2 and Bevacizumab for patients with progressive metastatic renal cell carcinoma. [During study (currently data no longer available)]
currently data no longer available

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell component)
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 profile.

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 study
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 treatment