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Protocol No. APEC1621I

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title NCI-COG Pediatric Match(MOLECULAR ANALYSIS FOR THERAPY CHOICE)-Phase 2 Subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes

Objective
You are being asked to take part in this research study because your tumor results from the NCI-COG Pediatric MATCH screening protocol make you a candidate to receive the investigational drug (or “study drug”) palbociclib that we are testing in this study
We are using palbociclib in this study because it has been shown to block the growth of cancer cells with mutations in an important biological pathway in test tubes and in animals. You are eligible for this study because your tumor was found to have a mutation in this pathway. Palbociclib is considered a study drug in the treatment of your tumor or type of cancer. Although palbociclib has been given to a small number of adults and children, we do not know if it will work against the type of tumor you have

Treatment Palbociclib will be given by mouth once daily for 21 days, followed by a rest period of 7 days. This entire 4 week period is called a cycle. You may continue to receive palbociclib for up to 2 years unless you develop serious side effects or your tumor worsens

Description Phase 2 Pediatric MATCH sub protocol of Palbociclib for activating alterations in cell cycle genes

Key Eligibility
  • APEC1621SC: Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621I based on the presence of an actionable mutation
  • Positive Rb expression by immunohistochemistry is required
  • Patients must be greater than or equal to 12 months and less than or equal to 21 years of age at the time of study enrollment
  • Patients must have a body surface area greater than or equal to 0.87 m2 at enrollment
  • Patients must have radiographically measurable disease
  • Karnofsky greater than or equal to 50% for patients greater than 16 years of age and Lansky greater than or equal to 50 for patients less than or equal to 16 years of age
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet minimum duration from prior anti-cancer directed therapy per protocol
  • Adequate Bone marrow, renal and liver function
  • Must be able to swallow intact capsules
    EXCLUSION
  • Can not be pregnant or breast feeding
  • Can not have an uncontrolled infection
  • No prior solid organ transplantation

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics