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

This study has been terminated.
(contract issues)
Sponsor:
Collaborator:
Genentech
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00440973
First received: February 23, 2007
Last updated: August 21, 2008
Last verified: August 2008
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Secondary Outcome Measures:
  • Collect data on tumor responses produced by interleukin-2 and Bevacizumab
  • Evaluate safety and toxicity of the combination of interleukin-2 and Bevacizumab for patients with progressive metastatic renal cell carcinoma.

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440973

Locations
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Genentech
Investigators
Principal Investigator: Robert J. Amato, D.O. The Methodist Hospital Research Institute
  More Information

No publications provided

Responsible Party: Robert J. Amato, DO, The Methodist Hospital Physician Organization
ClinicalTrials.gov Identifier: NCT00440973     History of Changes
Other Study ID Numbers: 16117, 03-0194-05
Study First Received: February 23, 2007
Last Updated: August 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
kidney cancer
M3thodist

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

ClinicalTrials.gov processed this record on August 28, 2014