Recruitment

Recruitment Status
Completed

Inclusion Criteria

prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
Human leukocyte antigen HLA A2 positive
Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
...
prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
Human leukocyte antigen HLA A2 positive
Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
blood urea nitrogen (BUN) < 30 mg/dL
hemoglobin (Hgb) > 9.9 g/dL
≥ 18 years of age
Any recurrence of a glioblastoma multiforme
platelet count > 100,000/mm3
Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
Female patients of child bearing potential must have negative serum pregnancy test
creatinine < 2 mg/dL
If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
absolute neutrophil count (ANC) > 1000/mm3
Ability to understand and the willingness to sign a written informed consent document.
alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN)
Karnofsky Performance Score (KPS) of ≥ 70%

Exclusion Criteria

Clinically significant abnormality on electrocardiogram (ECG)
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
...
Clinically significant abnormality on electrocardiogram (ECG)
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
Diagnosed or suspected congenital long QT syndrome
Known history of an autoimmune disorder
Breastfeeding
Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
Chronic renal disease / failure
Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
Uncontrolled angina within 6 months
Immunosuppressive disease
Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Contraindication to MRI
Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
Concurrent neurodegenerative disease,
Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer

Summary

Conditions
Glioblastoma Multiforme
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of ca...

Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of cancer cells and is associated with shortened survival. CD133 positive cancer stem cells are resistant to chemotherapy. Patients with recurrent glioblastoma who have the HLA A2 phenotype will receive autologous vaccine of DC pulsed with purified peptides from CD133. Approximately 20 patients with any recurrence of glioblastoma multiforme (GBM) will be treated. After informed consent and screening, patients will undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). Monocytes will be purified and cultured into dendritic cells (DC) that are pulsed with purified peptides from CD133 antigen. The pulsed dendritic cells will then be aliquoted and frozen. Patients will have the autologous DCs reinfused intradermally. Patients will receive at least four intradermal injections of the autologous DC vaccine and additional vaccines during a maintenance phase. The goal is to induce a cytotoxic T cell response to CD133 positive cells. The primary objective of the study is to assess safety and tolerability. Clinical response rates will be monitored as well as the immune responses to CD133.

Inclusion Criteria

prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
Human leukocyte antigen HLA A2 positive
Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
...
prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
Human leukocyte antigen HLA A2 positive
Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
blood urea nitrogen (BUN) < 30 mg/dL
hemoglobin (Hgb) > 9.9 g/dL
≥ 18 years of age
Any recurrence of a glioblastoma multiforme
platelet count > 100,000/mm3
Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
Female patients of child bearing potential must have negative serum pregnancy test
creatinine < 2 mg/dL
If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
absolute neutrophil count (ANC) > 1000/mm3
Ability to understand and the willingness to sign a written informed consent document.
alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN)
Karnofsky Performance Score (KPS) of ≥ 70%

Exclusion Criteria

Clinically significant abnormality on electrocardiogram (ECG)
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
...
Clinically significant abnormality on electrocardiogram (ECG)
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
Diagnosed or suspected congenital long QT syndrome
Known history of an autoimmune disorder
Breastfeeding
Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
Chronic renal disease / failure
Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
Uncontrolled angina within 6 months
Immunosuppressive disease
Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Contraindication to MRI
Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
Concurrent neurodegenerative disease,
Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer

Tracking Information

NCT #
NCT02049489
Collaborators
Not Provided
Investigators
Study Director: Anthony Gringeri, Ph.D. Precision Life Sciences Group