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A Multicenter Phase I Study of Deforolimus (AP23573) in Pediatric Patients with Advanced Solid Tumors
[Protocol 08-110]
- Full Title :
- A MULTI-CENTER PHASE I STUDY OF INTRAVENOUS DEFOROLIMUS (AP23573, MK-8669) ADMINISTERED QDX5 EVERY OTHER WEEK IN PEDIATRIC PATIENTS WITH ADVANCED SOLID TUMORS
- Purpose :
The main purpose of this study is to determine the highest dose of deforolimus (AP23573) that may be given safely in children and adolescents with advanced solid tumors that have failed to respond to standard anticancer drugs. Deforolimus is an investigational drug designed to stop cancer cells from growing by affecting a protein called mTOR. mTOR helps to control the production of other proteins needed for cancer cell growth.
Deforolimus has shown promising activity in treating adult patients with cancer, especially sarcomas. This study will evaluate the possible antitumor effects of deforolimus in children and adolescents, determine how the body breaks down the drug, and examine the effects of a person's genetic make-up on the drug's activity.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be aged one to less than 18 years and have a confirmed diagnosis of lymphoma or an advanced solid tumor that has persisted or progressed despite conventional therapy.
- Patients must have recovered from the acute side effects of prior therapies before entering the study.
- Patients may not have previously received deforolimus or other rapamycin analogs.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
For more information and to inquire about eligibility for this study, please contact Dr. Christine Pratilas at 212-639-3964 or Dr. Tanya Trippett at 212-639-8267.
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