A Phase I Trial of Dose Escalation of Metformin in Combination With Vincristine, Irinotecan, and Temozolomide in Children With Relapsed or Refractory Solid Tumors

Who is this study for? Pediatric patients age 1 year to 18 years with solid tumors including brain tumors
What treatments are being studied? Vincristine+Irinotecan+Temozolomide+Metformin
Status: Active, not recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1

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.

Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: No

• 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.

United States
Connecticut Children's Medical Center
Nemours/Alfred I. duPont Hospital for Children, Delaware
University of Florida
Nemours Children's Clinic
University of Miami Sylvester Comprehensive Cancer Center
Johns Hopkins All Children's Hospital
Saint Petersburg
H. Lee Moffitt Cancer Center and Research Institute
Tampa General Hospital
University of Kentucky
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
New York
The Children's Hospital at Montefiore
Nationwide Children's Hospital
Primary Children's Medical Center/Utah
Salt Lake City
Time Frame
Start Date: September 24, 2012
Estimated Completion Date: March 2023
Target number of participants: 26
Experimental: Metformin in Combination with VIT
Participants will receive metformin in combination with vincristine, irinotecan and temozolomide (VIT).
Related Therapeutic Areas
Collaborators: Pediatric Cancer Foundation
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov

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