Carcinoma, Renal CellPhase 2NCT00131651
ATN-161 in Advanced Renal Cell Cancer
A Phase 2 study testing ATN-161 in people with Carcinoma, Renal Cell, run by Attenuon at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- ATN-161
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- serum calcium ≤1 x ULN (the patient may be on treatment for hypercalcemia)
- The effects of ATN 161 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of ATN 161. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Similarly, if the partner of a male patient should become pregnant while he is participating in this study, he should inform his treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44165
University of California Irvine, Chao Family Comprehensive Cancer Center
Irvine, California, 92868
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer
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.
Read the detailed description
Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is a malignancy characterized by abundant vascularization and a high degree of resistance to chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This concept has been established by the initial successes observed in recent studies of antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as a therapeutic agent in CCRCC because it binds to several fully activated integrins, which are essential downstream components in the angiogenic signaling cascade.
Functional imaging using dceMRI has been demonstrated as an effective way to show effects on the vasculature across different tumors, including CCRCC. Preclinical experiments have shown that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in this study is expected to be an effective method for evaluating the antiangiogenic response to ATN-161.
Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at 1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of disease, unacceptable drug toxicity, or withdrawal of consent occurs.
Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again during the second week of treatment, and finally during the fourth week of treatment.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- ATN-161
- Keywords
- renal, cancer, advanced, unresectable, metastatic, recurrent, anti-angiogenic, targeted, ATN-161, Recurrent renal cell cancer, Renal clear cell carcinoma, Advanced Renal Cell Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-161Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Attenuon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131651
- Sponsor's protocol ID
- ATN-161-005
- Status last verified
- Dec 2007
- First submitted
- 17 Aug 2005
- Last updated
- 6 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00131651
- Acronym / sponsor ID
- ATN-161-005
- Conditions
- Carcinoma, Renal Cell
- Keywords
- renal, cancer, advanced, unresectable, metastatic, recurrent, anti-angiogenic, targeted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants
- Lead sponsor
- AttenuonIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is a malignancy characterized by abundant vascularization and a high degree of resistance to chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This concept has been established by the initial successes observed in recent studies of antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as a therapeutic agent in CCRCC because it binds to several fully activated integrins, which are essential downstream components in the angiogenic signaling cascade.
Functional imaging using dceMRI has been demonstrated as an effective way to show effects on the vasculature across different tumors, including CCRCC. Preclinical experiments have shown that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in this study is expected to be an effective method for evaluating the antiangiogenic response to ATN-161.
Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at 1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of disease, unacceptable drug toxicity, or withdrawal of consent occurs.
Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again during the second week of treatment, and finally during the fourth week of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATN-161 | Drug | – |
Primary outcome
Reduction in tumor blood flow and permeability of vessels
4 secondary outcomes
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)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATN-161 in people with Carcinoma, Renal Cell, run by Attenuon at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in tumor blood flow and permeability of vessels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007.