Overview

A Phase I Study of IMC-A12 in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors

Status:
Withdrawn
Trial end date:
2012-04-04
Target enrollment:
0
Participant gender:
All
Summary
Background: - IMC-A12 is an experimental substance designed to inhibit a protein called Type I Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can promote cancer growth. Temsirolimus is a drug that the U.S. Food and Drug Administration has approved to treat advanced renal cell carcinoma in adults. Researchers do not know if the combination of IMC-A12 and temsirolimus will work in children, but want to determine whether these two drugs may be an effective treatment for recurrent tumors. Objectives: - To determine the safety and effectiveness of IMC-A12 and temsirolimus in treating children and adolescents with solid tumors. - To determine possible side effects of the combination of IMC-A12 and temsirolimus. Eligibility: - Children and adolescents between 12 months and 21 years of age who have solid tumors that have not responded to or have relapsed after standard treatment. Design: - Participants will be screened with a medical history, physical examination, and imaging studies. - Participants will receive IMC-A12 and temsirolimus in 28-day cycles of treatment. IMC-A12 will be given as an infusion over 1 hour, once a week, for 4 weeks. Temsirolimus will also be given after IMC-A12 over 30 minutes, once a week, for 4 weeks. - Participants may continue to receive IMC-A12 and temsirolimus for up to 2 years unless serious side effects develop or the treatment stops being effective. - Participants will have additional physical exams, blood and urine tests, and imaging studies regularly during each treatment cycle. - Participants will be followed at regular intervals after the end of the study to collect tumor response and progression data....
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Everolimus
Sirolimus
Criteria
- Eligibility

- Patients > 12 months and less than or equal to 21 years of age with a diagnosis and
histologic verification (except patients with intrinsic brain stem tumors, optic
pathway gliomas or pineal tumors and elevations of serum or CSF alpha-fetoprotein or
beta-HCG) of measureable or evaluable relapsed or refractory solid tumors. Current
disease state must be one for which there is no known curative therapy, or therapy
proven to prolong survival.

- Must have fully recovered from acute toxic effects from all prior therapy, which has
been completed within the specified prior time frame.

- Have adequate organ function as determined by laboratory evaluation including normal
random or fasting blood glucose within the upper normal limits for age and grade < 2
serum cholesterol and triglyceride levels.

- Subjects with uncontrolled infection, known type I or type II diabetes mellitus, known
bone marrow involvement or who have received prior monoclonal antibody therapy
targeting IGF-1R or temsirolimus are not eligible.