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A Phase I Study of MDX1411 in Patients with Advanced or Recurrent Clear Cell Renal Cell Carcinoma
[Protocol 08-029]
- Full Title :
- A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION, MULTIDOSE STUDY OF MDX-1411 ADMINISTERED EVERY 14 DAYS IN SUBJECTS WITH ADVANCED OR RECURRENT CLEAR CELL RENAL CELL CARCINOMA
- Purpose :
The purpose of this study is to find the highest dose of MDX1411 that can be given safely to patients with advanced clear cell renal cell carcinoma (metastatic kidney cancer) that has persisted or returned despite standard treatment. Researchers will also see how patients' tumors respond to the drug, although that it not the primary goal of the study.
MDX1411 is an antibody that can bind to the outside of clear cell kidney cancer cells and very few normal cells in the body. Laboratory research has shown that MDX1411 may stop or slow down the growth of some cancer cells.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of advanced clear cell renal cell carcinoma that has persisted or returned despite at least one but no more than three prior regimens of systemic therapy that included sunitinib, temsirolimus, sorafenib, IL-2, and/or chemotherapy.
- At least 4 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Glenn Kroog at 646-422-4313.
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