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

NCT00440973 | Terminated Phase 2

• 2 other identifiers: PAC IRB #03-0194-0516117
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

kidney cancer; M3thodist

Outcome Measures

Primary Outcomes (1)

• time to progression

  currently data no longer available

  During study (currently data no longer available)

Secondary Outcomes (2)

• Collect data on tumor responses produced by interleukin-2 and Bevacizumab

  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.

  During study (currently data no longer available)

Study Arms (1)

treatment arm

OTHER

PI relocated, currently data is no longer available

Drug: Bevacizumab; Drug: Interleukin-2

Interventions

Bevacizumab DRUG

monoclonal antibody with anti-angiogenesis properties used as chemotherapy

Also known as: Avastin

treatment arm

Interleukin-2 DRUG

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

Also known as: IL-2

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Bevacizumab; Interleukin-2

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors

Study Officials

• Robert J. Amato, D.O.

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)