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

March 15, 2016 updated by: The Methodist Hospital Research Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to progression
Time Frame: During study (currently data no longer available)
currently data no longer available
During study (currently data no longer available)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect data on tumor responses produced by interleukin-2 and Bevacizumab
Time Frame: During study (currently data no longer available)
currently data no longer available
During study (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.
Time Frame: During study (currently data no longer available)
currently data no longer available
During study (currently data no longer available)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Robert J. Amato, D.O., Baylor College of Medicine - Methodist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAC IRB #03-0194-05
  • 16117 (Other Identifier: Principal Investigator)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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