Metformin in Children With Relapsed or Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors, Primary Brain Tumors

In brief

The purpose of this study is to evaluate the tolerability and safety of escalating doses of metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with recurrent and refractory solid tumors.

Key facts

Study ID

NCT01528046

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

26

Starts

2012-09-24

Expected to finish

2020-02-03

Last updated by the study team

2023-01-13

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Patients must be > 1 year of age and ≤ 18 years of age at time of initiation of protocol therapy.
• Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor or primary central nervous system (CNS) malignancy.
• Disease Status: Patients must have radiographically measurable disease.
• Therapeutic Options: Patients must have relapsed or refractory cancers for which there is no known curative option or other available therapy proven to prolong survival with an acceptable quality of life.
• Performance Level: Karnofsky ≥ 50% for patients older than 16 years old, and Lansky ≥ 50 for patients 1-16 years old.
• Prior Therapy: Patients may have received prior therapy including vincristine, irinotecan, or temozolomide. Patients may not have previously been treated with combination therapy of irinotecan and temozolomide.
• Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
• Myelosuppressive chemotherapy: Patients must not have received myelosuppressive chemotherapy within 3 weeks of starting protocol therapy, or a minimum of six weeks must have elapsed since prior nitrosurea chemotherapy.
• Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim.
• Biologic (anti-neoplastic agent): At least 7 must have elapsed since the last administration of any biologic agent.
• Radiation therapy (XRT): At least 14 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation.
• Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors.
• Organ Function Requirements
• Bone Marrow Function: Peripheral absolute neutrophil count (ANC) ≥ 1000/μL; Platelet count ≥ 100,000/μL (no platelet transfusion within 7 days prior to obtaining laboratory result); Hemoglobin ≥ 8.0 gm/dL
• Adequate Renal Function: Creatinine clearance or glomerular filtration rate ≥ 70ml/min/1.73m\^2
• Adequate Liver Function: Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age; alanine transaminase (ALT) ≤ 5x ULN; Serum albumin ≥ 2gm/dL
• Informed Consent: All patients ≥ 18 years of age must sign a written informed consent. For patients < 18 years old, the patient's parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor. Childhood Assent, when age appropriate as per institutional guidelines, should be signed by the participating patient.

You may not qualify if…

• Significant organ dysfunction, not meeting inclusion criteria.
• Pregnancy or Breast-Feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
• Concomitant Medications:
• Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.
• Steroids: Patients with CNS tumors who have not been on a stable or decreasing dose of dexamethasone for the past 7 days.
• Investigational Drugs: Patients who are currently receiving another investigational drug.
• Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents.
• Medication Allergy: Allergy or intolerance to agents on this protocol: vincristine, irinotecan, temozolomide, or metformin; Allergy to cephalosporins.
• Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Primary Children's Medical Center/Utah — Salt Lake City, Utah, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Nemours/Alfred I. duPont Hospital for Children, Delaware — Wilmington, Delaware, United States
• University of Florida — Gainesville, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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