The investigators have developed a phase I/II clinical trial to evaluate the effect of
rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG).
A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with
HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard
3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte
counts will use placebo-controlled randomization in HGG patients whose treatment include the
standard radiation therapy (RT) and temozolomide (TMZ).
Inclusion Criteria:
- World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas
that require RT and TMZ treatment.
- Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers
are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is
allowed.
- Adequate organ and marrow function defined as follows:
- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 75,000/mcL
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 3.0 x institutional upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal
- Absolute lymphocyte count (ALC) ≥ 600/mcL
- Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for
himself/herself with occasional help from others).
- Able to provide written informed consent (or consent from a legally authorized
representative).
- Women of childbearing potential must have a negative serum pregnancy test prior to
study entry (within 14 days). Patients must be willing to be on adequate contraception
during treatment.
- 18 years of age.
Exclusion Criteria:
- Receiving any other investigational agents which may affect patient's lymphocyte
counts.
- Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated
regarding its potential for teratogenic or abortifacients effects. There is a
potential risk for adverse events in nursing infants secondary to treatment of the
mother with the study drug, breastfeeding should be discontinued if the mother is
treated with rhIL-7-hyFc.
- Has an active viral infection requiring systemic treatment at screening.
- Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid
arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis,
Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative
colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires
systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment. Subjects are permitted
to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes
mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger.
- Receipt of live attenuated vaccine within 30 days before the first dose of study
treatment. Examples of live vaccines include, but are not limited to, the following:
measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin
(BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are
generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
