Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma

NCT02768389 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: CASE10314
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD). The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.

Conditions

Glioblastoma; Brain Tumor

Keywords

Modified Atkins Diet; MAD; Brain Tumor; Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Number of subjects following Modified Atkins Diet

  The number of patients following a Modified Atkins Diet for at least 80% of the time as a measure of feasibility

  Up to 12 weeks

• Number of subjects with ketosis

  The number of patients with documented ketosis (Serum beta-hydroxybutyrate (BHB) above 4mg/L) for at least 80% of the time as a measure of feasibility

  Up to 12 weeks

Secondary Outcomes (4)

• Correlation of blood sugar levels by compliance level

  Up to 12 weeks

• Correlation of ketosis values by compliance level

  Up to 12 weeks

• Correlation of ketosis values by tumor response

  Up to 12 weeks

• Correlation of blood sugar levels by tumor response

  Up to 12 weeks

Study Arms (1)

Modified Atkins Diet and Bevacizumab

EXPERIMENTAL

Patients and caregivers will be educated by a nutritionist skilled in the MAD. Patients will also be receiving Bevacizumab as standard of care.

Drug: Bevacizumab; Behavioral: Modified Atkins Diet

Interventions

Bevacizumab DRUG

Subjects receive Bevacizumab as standard of care

Modified Atkins Diet and Bevacizumab

Modified Atkins Diet BEHAVIORAL

The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\< 20gm/day).

Also known as: MAD

Modified Atkins Diet and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external beam fractionated radiotherapy and temozolomide chemotherapy.
• Any number of prior recurrences are allowed
• Karnofsky Performance status ≥60
• Patients must have normal organ and marrow function as defined below:
• Hemoglobin ≥ 9.0 g/dl
• Absolute neutrophil count ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Total bilirubin ≤ 1.5 X institutional upper limit of normal
• Aspartate aminotransferase (AST) (SGOT) ≤ 3.0x institutional upper limit of normal
• Alanine aminotransferase (ALT) (SGPT) ≤ 3.0x institutional upper limit of normal
• Serum Creatinine ≤ 1.5 X institutional upper limit of normal
• Cr \<2, blood urea nitrogen (BUN) \< 100mg/dL
• Blood coagulation parameters: international normalized ratio (INR) ≤ 1.5
• Minimum interval since last drug therapy;
• weeks since last non-cytotoxic therapy

You may not qualify if:

• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab.
• Patients who have had previous treatment with bevacizumab.
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active bowel instruction, diabetic (insulin dependent), Active or remote pancreatitis, Pancreatic insufficiency, symptomatic congestive heart failure (NYHA \> 2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding women are excluded from this study because bevacizumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with bevacizumab, breastfeeding should be discontinued if the mother is treated with bevacizumab. These potential risks may also apply to other agents used in this study.
• Known diagnosis of human immunodeficiency virus (HIV). (HIV testing is not required).
• Patients who have undergone major surgery (ie, intra-thoracic, intra abdominal or inra-pelvic), open biopsy or significant traumatic injury =\< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of previous procedure or injury.
• Patients with cirrhosis, or active viral or nonviral hepatitis.
• Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias.
• Evidence of increased intracranial pressure (clinically significant papilledema, vomiting, and nausea, or reduced level of consciousness).
• Patients who are unwilling to comply with protocol.
• Myocardial infarction within the last 6 months.
• Symptomatic atrial fibrillation.
• Patients with a body mass index (BMI) \>35, \< 20.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• University of Cincinnati: collaborator
• OhioHealth Research Institute: collaborator

Study Sites (4)

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer Center

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Bevacizumab; mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lisa Rogers, DO

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: September 6, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

US (4)