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

This study has been terminated.
(contract issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440973
First Posted: February 27, 2007
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
The Methodist Hospital System
  Purpose
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 Intervention Phase
Carcinoma, Renal Cell Drug: Bevacizumab Drug: Interleukin-2 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • time to progression [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: During study (currently data no longer available) ]
    currently data no longer available


Enrollment: 6
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
treatment arm
PI relocated, currently data is no longer available
Drug: Bevacizumab
monoclonal antibody with anti-angiogenesis properties used as chemotherapy
Other Name: Avastin
Drug: Interleukin-2
immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T & B lymphocyte proliferation
Other Name: IL-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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440973


Locations
United States, Texas
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Genentech, Inc.
Investigators
Principal Investigator: Robert J. Amato, D.O. Baylor College of Medicine - Methodist Hospital
  More Information

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00440973     History of Changes
Other Study ID Numbers: PAC IRB #03-0194-05
16117 ( Other Identifier: Principal Investigator )
First Submitted: February 23, 2007
First Posted: February 27, 2007
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
kidney cancer
M3thodist

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Interleukin-2
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents