Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, 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.]

NCT02659800 : IL-7 in Increasing Low CD4 Counts After Concurrent Radiation and Temozolomide Treatment in Patients With High Grade Gliomas
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- • Patients must have histologically confirmed high grade glioma by pathology (World
Health Organization [WHO] grade III and IV)

- Patients' post-operative treatment must have included at least 80% of standard
radiation and concomitant temozolomide; patients may not have received any other
prior chemotherapy, immunotherapy or therapy with biologic agent (including
immunotoxins, immunoconjugates, antisense, peptide receptor antagonists,
interferons, interleukins, tumor infiltrating lymphocytes [TIL],
lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for
their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is
allowed

- Patients must have CD4 =< 200 cells/mm^3 in the last week (7 days) of standard
radiation + temozolomide treatment

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 9 g/dL

- Total bilirubin =< institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase
[SGPT]) =< 2.5 x institutional upper limit of normal

- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60
ml/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Activated partial thromboplastin time (APTT) or partial thromboplastin time
(PTT) =< 1.5 x institutional upper limit of normal

- Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient
must be able to care for himself/herself with occasional help from others)

- Patients must be able to provide written informed consent

- Women of childbearing potential must have a negative serum pregnancy test prior
to study entry; women of childbearing potential and men must agree to use two
birth control methods (either two barrier methods or a barrier method plus a
hormonal method) or abstinence prior to study entry and for the duration of
study participation (through at least 30 days after the last study injection);
should a woman become pregnant or suspect she is pregnant while participating in
this study, she should inform her treating physician immediately

- Patients must have no concurrent malignancy except curatively treated basal or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast,
or bladder; patients with prior malignancies must be disease-free for >= five
years

- Dexamethasone dose must be provided for treatment stratification:

- Group A: patients not on dexamethasone or on a dose =< 0.75mg daily (or
equivalent of an alternative corticosteroid)

- Group B: patients who require dexamethasone > 0.75mg daily (or equivalent
of an alternative corticosteroid) ** Corticosteroid dose changes prior to
the start of treatment are allowed as long as they do not alter patient's
group assignment

Exclusion Criteria:

- • Patients must have histologically confirmed high grade glioma by pathology (World
Health Organization [WHO] grade III and IV)

- Patients' post-operative treatment must have included at least 80% of standard
radiation and concomitant temozolomide; patients may not have received any other
prior chemotherapy, immunotherapy or therapy with biologic agent (including
immunotoxins, immunoconjugates, antisense, peptide receptor antagonists,
interferons, interleukins, tumor infiltrating lymphocytes [TIL],
lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for
their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is
allowed

- Patients must have CD4 =< 200 cells/mm^3 in the last week (7 days) of standard
radiation + temozolomide treatment

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 9 g/dL

- Total bilirubin =< institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase
[SGPT]) =< 2.5 x institutional upper limit of normal

- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60
ml/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Activated partial thromboplastin time (APTT) or partial thromboplastin time
(PTT) =< 1.5 x institutional upper limit of normal

- Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient
must be able to care for himself/herself with occasional help from others)

- Patients must be able to provide written informed consent

- Women of childbearing potential must have a negative serum pregnancy test prior
to study entry; women of childbearing potential and men must agree to use two
birth control methods (either two barrier methods or a barrier method plus a
hormonal method) or abstinence prior to study entry and for the duration of
study participation (through at least 30 days after the last study injection);
should a woman become pregnant or suspect she is pregnant while participating in
this study, she should inform her treating physician immediately

- Patients must have no concurrent malignancy except curatively treated basal or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast,
or bladder; patients with prior malignancies must be disease-free for >= five
years

- Dexamethasone dose must be provided for treatment stratification:

- Group A: patients not on dexamethasone or on a dose =< 0.75mg daily (or
equivalent of an alternative corticosteroid)

- Group B: patients who require dexamethasone > 0.75mg daily (or equivalent
of an alternative corticosteroid) ** Corticosteroid dose changes prior to
the start of treatment are allowed as long as they do not alter patient's
group assignment

Exclusion Criteria:

- Patients receiving any other investigational agents are ineligible

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements, are ineligible

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with CYT107

- Patients with human immunodeficiency virus (HIV) are excluded
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02659800      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: UAB Comprehensive Cancer Center
Investigator: Burt Nabors, MD
Contact: Thiru Pillay, RN Phone: 205-934-1842
Click HERE to send email to this center

Baltimore, Maryland
Facility: Johns Hopkins Oncology Center
Investigator: Stuart A Grossman, MD
Contact: Joy D Fisher, CCRP Phone: 410-955-8837
Click HERE to send email to this center

Detroit, Michigan
Facility: Josephine Ford Cancer Center at Henry Ford Hospital
Investigator: Tobias Walbert, MD
Contact: Amy Williamson, RN
Click HERE to send email to this center

St Louis, Missouri
Facility: Washington University
Investigator: Jian Campian, MD
Contact: Jian L Campian, MD Phone: 314-747-4241
Email not avaialable

New York, New York
Facility: Memorial Sloan-Kettering Cancer Center
Investigator: Antonio Omuro, MD
Contact: Antonio Omuro, MD Phone: 212-639-7523
Email not avaialable

Winston-Salem, North Carolina
Facility: Wake Forest University Comprehensive Cancer Center
Investigator: Glenn Lesser, MD
Contact: Clinical Trials Office - Wake Forest University CCC Phone: 336-713-6771
Email not avaialable




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