Study of Safety and Effects of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
NCT00520533
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Metastatic or unresectable Renal Cell Cancer (with clear cell component).
- Measurable disease by RECIST on CT with at least one measurable lesion 2 cm or greater in diameter, which is deemed to be assessable by PET imaging.
- At least 4 weeks after chemotherapy, radiotherapy or immunotherapy (6 weeks for nitrosourea drugs).
- Expected survival at least 3 months.
- Karnofsky performance status (KPS) of 70% or greater.
- Age 18 years or older.
- Vital laboratory parameters within normal, or protocol specified ranges.
- Left ventricular ejection fraction greater than 55% on GCBP scan.
- Systolic blood pressure ≤150mmHg and diastolic blood pressure ≤90mmHg
- Able to give written informed consent.
- Prior exposure to cG250 monoclonal antibody (exception: no circulating human
anti-chimeric antibody to cG250).
- Prior treatment with VEGF-targeting agents (e.g. bevacizumab) or multi-kinase
inhibitors (e.g. sorafenib) not including sunitinib. (Patients currently receiving
sunitinib may be eligible if tolerating a stable dose of sunitinib on a four week on /
two week off regimen, with toxicity due to sunitinib ≤ CTCAE grade 2; and for whom the
investigator deems it clinically reasonable to withhold sunitinib for at least four
weeks prior to commencement of study treatment.)
- Active central nervous system (CNS) metastases (exception: CNS metastases adequately
treated (surgery or radiotherapy) with no progression for at least three months).
- Known HIV positivity.
- Clinically significant heart disease.
- History of hypertension requiring hospitalisation.
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding
disorders.
- Major surgery or radiation therapy within 4 weeks prior to, or planned within 6 weeks
of starting the study treatment. (Prior palliative radiotherapy to metastatic
lesion(s) permitted, provided at least one measurable lesion was not irradiated or has
progressed following radiotherapy)
- Severe haemorrhage within 4 weeks prior to starting the study treatment.
- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.
- Pre-existing thyroid abnormality with unstable thyroid function despite medication.
- Ongoing moderate to severe cardiac dysrhythmias, any severity of atrial fibrillation,
or prolongation of the QTc interval to greater than 450 msec for males or 470 msec for
females.
- Participation in a clinical trial involving another investigational agent within 4
weeks.
- Pregnancy or breastfeeding.
- Women of childbearing potential not using a medically acceptable means of
contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed
consent.
- Not available for follow-up assessment.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
- Houston, Texas
- Houston, Texas
- New York, New York
- Toronto, Ontario
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study of Safety and Effects of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma | |||
Official Title ICMJE | A Pilot Study of the Safety, Efficacy, and Effects on Functional Imaging of the Combination of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma | |||
Brief Summary | This clinical trial explores the safety, efficacy, and effects on functional imaging of the combination of cG250 monoclonal antibody administered intravenously weekly in combination with daily oral sunitinib, in patients with advanced renal cell carcinoma. | |||
Detailed Description | This study explores the safety, efficacy and effects on functional imaging of the combination of cG250 and sunitinib in patients with advanced renal cell carcinoma (kidney cancer). When kidney cancer has spread beyond the kidney it is usually not possible to cure it with surgery. Other treatments such as radiotherapy or chemotherapy are also of limited value. Kidney cancers often rely on certain proteins for their growth, particularly proteins that affect the ways that blood vessels grow into the cancer. Ingrowth of blood vessels supplies cancer cells with oxygen and nutrition; without the blood vessels, cancer deposits can not grow in size. When growth of the blood vessels is blocked, established cancers may stop growing or may shrink. This has been shown to work for some drugs that target this process in kidney cancers. One of these drugs is called sunitinib. A protein, called G250, is also thought to be important in helping kidney cancers to grow. G250 is found on the cell surface of many kidney cancers. One possible method of interfering with the function of G250 is to target G250 with an antibody known as cG250. Clinical trials with cG250 and have shown it to be safe, to home in on kidney cancer cells, and to persist in the blood and the cancer tissue for a long period of time. The main purpose of this study is to explore whether the combination of sunitinib and cG250 is safe in patients with advanced kidney cancer. The study will also assess whether this combination is able to cause kidney cancer to shrink; will determine where cG250 travels within the body, whether the immune system reacts to the cG250 and whether sunitinib affects that; and whether the combination affects how kidney cancers grow or how blood flows within the tumour. Patients with advanced kidney cancer who have never previously received cG250, sunitinib (or similar drugs) may be eligible to participate in the study. A total of 14 patients are expected to be recruited. Eligible patients will receive cG250 10 mg/m² by weekly intravenous infusion for five weeks, followed by a two-week break (one cycle). The first and fifth dose will be trace-labeled with a radioactive substance (¹²?I-cG250) detectable by a special scan called a Positron Emission Tomography (PET scan) to allow studies of the distribution of cG250. Sunitinib 50 mg by daily oral dose will also be given for 4 weeks (commencing on day 8 of the first treatment cycle), followed by a two-week break. Up to two cycles of treatment will be given. If a second cycle is given, cG250 will be given as four weekly doses and daily sunitinib will start on the same day. No ¹²?I-cG250 will be administered after the first treatment cycle. The extent of the kidney cancer will be assessed by CT scan at baseline and at the end of each treatment cycle. Safety assessments (physical examination, blood tests, gated cardiac blood pool scan, ECG-heart trace) will be performed at the beginning of each treatment cycle, repeated throughout the cycle and end of study. A number of blood tests and PET scans will be done in the first cycle to show how and in what amounts the ¹²?I-cG250 distributes in the body. Other PET scans ([18]F-FDG and [15]O-H?O) will be performed to allow assessment of tumour growth and blood flow. Blood tests will also show whether the immune system recognises the infused cG250 by making an antibody against it. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Renal Cell Carcinoma | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: On Study
Treatment (cycle 1):
Treatment (cycle 2 - investigator discretion):
Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 6 | |||
Original Estimated Enrollment ICMJE | 14 | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00520533 | |||
Other Study ID Numbers ICMJE | LUD2007-004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Linda Pan, Pharm.D. Assistant Director, Clinical Trials Management, Ludwig Institute for Cancer Research | |||
Study Sponsor ICMJE | Ludwig Institute for Cancer Research | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | Ludwig Institute for Cancer Research | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |