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Withdrawn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:
Participant gender:
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....