Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01528046 : Metformin in Children With Relapsed or Refractory Solid Tumors
PhasePhase 1
AgesMin: 1 Year Max: 18 Years
Inclusion Criteria:

- 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/?L;
Platelet count ? 100,000/?L (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 ?

- 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.

Exclusion Criteria:

- 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

- 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
LinksPermanent Link to THIS page:      |      Link to official listing
Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator: Michael Isakoff, M.D.
Contact: Robin Arens Phone: 860-545-9637
Click HERE to send email to this center

Wilmington, Delaware
Facility: Nemours/Alfred I. duPont Hospital for Children, Delaware
Investigator: Edward A. Kolb, M.D.
Contact: Debra J. Bertz Phone: 302-651-5757
Click HERE to send email to this center

Jacksonville, Florida
Facility: Nemours Children's Clinic
Investigator: Scott Bradfield, M.D.
Contact: Ingrid Ingram Phone: 904-697-3985
Click HERE to send email to this center

Miami, Florida
Facility: Holtz Children's Hospital at the University of Miami
Investigator: John Goldberg, M.D.
Contact: Myriam Zayas Phone: 305-243-7846
Click HERE to send email to this center

Saint Petersburg, Florida
Facility: Johns Hopkins All Children's Hospital
Investigator: Damon Reed, M.D.
Contact: Ashley Repp, RN Phone: 727-767-4784
Click HERE to send email to this center

Tampa, Florida
Facility: Tampa General Hospital
Investigator: Cameron Tebbi, M.D.
Contact: Denise Fife Phone: 813-844-7829
Click HERE to send email to this center

Lexington, Kentucky
Facility: University of Kentucky
Investigator: Lars Wagner, M.D.
Contact: Tammy Taylor Phone: 859-323-6975
Click HERE to send email to this center

Baltimore, Maryland
Facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Investigator: David Loeb, M.D.
Contact: David Loeb, M.D. Phone: 410-502-7247
Click HERE to send email to this center

Bronx, New York
Facility: The Children's Hospital at Montefiore
Investigator: Jonathan Gill, M.D.
Contact: Noam Zeffren Phone: 718-741-2356
Click HERE to send email to this center

Chapel Hill, North Carolina
Facility: University of North Carolina at Chapel Hill
Investigator: Patrick Thompson, M.D.
Contact: Sharon Guerry Phone: 919-966-1178
Email not avaialable

Columbus, Ohio
Facility: Nationwide Children's Hospital
Investigator: Bhuvana Setty, M.D.
Contact: Amy Yekisa Phone: 614-722-6570
Click HERE to send email to this center

Salt Lake City, Utah
Facility: Primary Children's Medical Center/Utah
Investigator: Holly Spraker-Perlman, M.D.
Contact: Melissa Bolton Phone: 801-213-3909
Click HERE to send email to this center

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