ATN-161 in Advanced Renal Cell Cancer

NCT00131651 | Terminated Phase 2

• 1 other identifier: ATN-161-005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer.

Conditions

Carcinoma, Renal Cell

Keywords

renal; cancer; advanced; unresectable; metastatic; recurrent; anti-angiogenic; targeted; ATN-161; Recurrent renal cell cancer; Renal clear cell carcinoma; Advanced Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Reduction in tumor blood flow and permeability of vessels

Secondary Outcomes (4)

• Response rate (time to progression, rate of objective response, and rate and duration of disease control)

• Safety (adverse events [AEs], lab tests and physical examinations)

• Reduction in circulating endothelial cells (CECs)

• Reduction in circulating endothelial progenitor cells (CEPs)

Interventions

ATN-161 DRUG

Eligibility Criteria

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

You may qualify if:

• Patients must have unresectable and/or metastatic kidney cancer with a component of clear cell adenocarcinoma that is histologically confirmed. A pathologist at the investigator's institution must have reviewed the material sent by outside institutions and confirm the diagnosis.
• Patients must have been previously treated with at least one FDA-approved therapy or commonly used treatment (such as interferon or low dose interleukin-2) for advanced kidney cancer. Any number of other prior treatments, approved or investigational, is acceptable.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as 2 times the measurable slice width with spiral CT scan. See RECIST Appendix B for the evaluation of measurable disease.
• Patients must have at least one lesion amenable to dceMRI as per lesion guidelines (see Section 8.1.1).
• Age ≥18 years.
• ECOG performance status of 0 or 1 (see Appendix A).
• Patients must have recovered from the reversible effects of prior treatment (with the exception of alopecia) by returning to normal or mild severity (Grade 1) or their pre-treatment baseline.
• Life expectancy of greater than three months.
• Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count ≥1,500 cells/mm3
• platelets ≥100,000 cells/mm3
• total bilirubin ≤1.5 mg/dL
• AST (SGOT) and ALT (SGPT) ≤1.5 x institutional upper limit of normal (ULN) (≤2.5 x ULN for patients with liver metastases)
• alkaline phosphatase ≤5.0 x ULN
• serum creatinine ≤1.5 x ULN

You may not qualify if:

• Patients who have not recovered from reversible adverse events due to previously-administered agents.
• Patients may not be receiving any agents, approved or investigational, for the treatment of CCRCC, and may not be receiving any investigational agents for other conditions.
• Patients with documented brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Institutional practices should be followed to establish the absence of brain metastases.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because ATN 161 is an antiangiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ATN 161, breastfeeding should be discontinued if the mother is treated with ATN 161.
• Patients known to be human immunodeficiency virus (HIV)-positive are excluded.
• Patients who cannot undergo dceMRI analysis for any reason.
• Patients who do not have adequate wound healing based on clinical judgment following a major surgical intervention.

Sponsors & Collaborators

• Attenuon: lead

Study Sites (4)

University of California Irvine, Chao Family Comprehensive Cancer Center

Irvine, California, 92868, United States

Location

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44165, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

acetyl-prolyl-histidyl-seryl-cysteinyl-asparaginamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: August 1, 2005
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

US (4)