Protocol Summary

Protocol No.: PSCI-19-047
Prinicipal Investigator: Brown, Valerie
Phase: Phase I
Age Group: Children
Scope: Local
Secondary Protocol No.: A5481092
Title: Phase 1 Study To Evaluate the Safety and Pharmacokinetics of Palbociclib (Ibrance?) in Combination with Irinotecan and Temozolomide in Pediatric Patients with Recurrent or Refractory Solid Tumors
Objective: Primary Objective(s):To estimate the MTD for the combination of palbociclib, TMZ, and IRN in children, adolescents, and young adults with recurrent or refractory solid tumors.
Applicable Disease Sites: Abdominal; Anus; Bones and Joints; Brain and Nervous System; Breast; Cervix; Colon; Corpus Uteri; Esophagus; Eye and Orbit; Head and Neck; Kaposi's Sarcoma; Kidney; Larynx; Lip, Oral Cavity and Pharynx; Liver; Lung; Melanoma, Skin; Other Digestive Organ; Other Endocrine System; Other Female Genital; Other Gastrointestinal; Other Hematopoietic; Other Male Genital; Other Respiratory and Intrathoracic Organs; Other Skin; Other Urinary; Ovary; Pancreas; Prostate; Rectum; Small Intestine; Soft Tissue; Stomach; Thymus; Thyroid; Urinary Bladder
Status: Open
Participating Institutions: Hershey Medical Center