Metformin in Children With Relapsed or Refractory Solid Tumors
NCT ID: NCT01528046
Last Updated: 2023-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2012-09-24
2020-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metformin in Combination with VIT
Participants will receive metformin in combination with vincristine, irinotecan and temozolomide (VIT).
Vincristine
Vincristine (VCR) = 1.5 mg/m\^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes
Irinotecan
Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes
Temozolomide
Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5
Metformin
Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.
Interventions
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Vincristine
Vincristine (VCR) = 1.5 mg/m\^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes
Irinotecan
Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes
Temozolomide
Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5
Metformin
Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
1 Year
18 Years
ALL
No
Sponsors
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Pediatric Cancer Foundation
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jonathan Gill, M.D.
Role: STUDY_CHAIR
The Children's Hospital at Montefiore, Pediatric Cancer Foundation, Sunshine Project
Damon Reed, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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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
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
Countries
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References
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Metts JL, Trucco M, Weiser DA, Thompson P, Sandler E, Smith T, Crimella J, Sansil S, Thapa R, Fridley BL, Llosa N, Badgett T, Gorlick R, Reed D, Gill J. A phase I trial of metformin in combination with vincristine, irinotecan, and temozolomide in children with relapsed or refractory solid and central nervous system tumors: A report from the national pediatric cancer foundation. Cancer Med. 2023 Feb;12(4):4270-4281. doi: 10.1002/cam4.5297. Epub 2022 Sep 23.
Other Identifiers
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SP003
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MCC-16962
Identifier Type: -
Identifier Source: org_study_id
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