Study of Safety and Effects of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

2014-08-27 03:36:34 | BioPortfolio


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.


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 (¹²⁴I-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 ¹²⁴I-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 ¹²⁴I-cG250 distributes in the body. Other PET scans ([18]F-FDG and [15]O-H₂O) 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Renal Cell Carcinoma


Chimeric monoclonal antibody cG250, Sunitinib malate


Austin Health (Ludwig Institute Oncology Unit)
Heidelberg (Melbourne)




Ludwig Institute for Cancer Research

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:36:34-0400

Clinical Trials [3152 Associated Clinical Trials listed on BioPortfolio]

Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination....

Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safe...

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread to nea...

Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma

This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic ...

Pre-surgical Detection of Clear Cell Renal Cell Carcinoma Using Radiolabeled G250-Antibody

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

PubMed Articles [19952 Associated PubMed Articles listed on BioPortfolio]

Relationships between sunitinib plasma concentration and clinical outcomes in Japanese patients with metastatic renal cell carcinoma.

The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with ...

NT5E inhibition suppresses the growth of sunitinib-resistant cells and EMT course and AKT/GSK-3β signaling pathway in renal cell cancer.

We aimed to explore the mechanisms of sunitinib-resistance in renal cell cancer (RCC) and provide new therapeutic evidence and biomarkers for RCC treatment using human clear-cell renal cell carcinoma ...

Candidate MicroRNA Biomarkers of Therapeutic Response to Sunitinib in Metastatic Renal Cell Carcinoma: A Validation Study in Patients with Extremely Good and Poor Response.

Targeted therapy with the tyrosine kinase inhibitor sunitinib is used in the first line of metastatic renal cell carcinoma (mRCC) treatment. The aim of the present study was independent validation of ...

RCAN1.4 acts as a suppressor of cancer progression and sunitinib resistance in clear cell renal cell carcinoma.

Clear cell renal cell carcinoma (ccRCC) is one of the most common malignant tumors in the urinary system, and its incidence continues to increase. Regulator of calcineurin 1 (RCAN1), one of the genes ...

Obinutuzumab, a new anti-CD20 antibody, and chlorambucil are active and effective in anti-MAG antibody polyneuropathy.

Rituximab, a chimeric anti-CD20 monoclonal antibody (mAb), has been used in polyneuropathy associated with anti-MAG antibody polyneuropathy with controversial results. Herein, we report on two patient...

Medical and Biotech [MESH] Definitions

A chimeric monoclonal antibody that functions as an ANTINEOPLASTIC AGENT through its binding to the EPIDERMAL GROWTH FACTOR RECEPTOR, where it prevents the binding and signaling action of cell growth and survival factors.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

An anti-CD52 ANTIGEN monoclonal antibody used for the treatment of certain types of CD52-positive lymphomas (e.g., CHRONIC LYMPHOCYTIC LEUKEMIA; CUTANEOUS T-CELL LYMPHOMA; and T-CELL LYMPHOMA). Its mode of actions include ANTIBODY-DEPENDENT CELL CYTOTOXICITY.

An enzyme that catalyzes the conversion of (S)-malate and NAD+ to oxaloacetate and NADH. EC

An anti-VEGF recombinant monoclonal antibody consisting of humanized murine antibody. It inhibits VEGF receptors and prevents the proliferation of blood vessels.

More From BioPortfolio on "Study of Safety and Effects of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type.  In renal cell cancer the cancerous cells start in the lini...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Trial