Overview

PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
howard safran
Collaborators:
Maine Medical Center Research Institute
MaineHealth
Rhode Island Hospital
Treatments:
Temozolomide
Criteria
Inclusion Criteria:

- Patients must have histopathologically confirmed, newly diagnosed, glioblastoma
multiforme or anaplastic glioma (anaplastic astrocytoma [AA], anaplastic
oligodendroglioma, and anaplastic oligoastrocytoma) and have not had a complete
surgical resection.

- Patients must be 18 years of age or older.

- Patients must have a Zubrod performance status 0-2.

- Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be
on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any
anti-epileptic drugs.

- Patients must not have received prior chemotherapy, radiation or any experimental
therapy for their glioblastoma.

- Patients may not be breast-feeding a child.

- Female patients must either be not of child bearing potential or have a negative
pregnancy test within 14 days of starting study treatment. Patients are considered not
of child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal. Pregnant or lactating females are not eligible. Should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately.

- Female patients must be using an acceptable method of contraception (oral
contraceptives, barrier methods, approved contraceptive implant, long-term injectable
contraception, intrauterine device or tubal ligation) OR female patients must be at
least 1-year post-menopausal or surgically sterile during their participation in this
study (from the time they sign the consent form) to prevent pregnancy. Male patients
must be surgically sterile or using an acceptable method of contraception during their
participation in this study (from the time they sign the consent form) to prevent
pregnancy in a partner

- Patients must have no concurrent malignancy except curatively treated basal or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast.
Patients with prior malignancies must be disease-free for ≥ 2 years.

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count > 1,500/ul

- Platelets > 100,000/ul

- Hemoglobin > 8 gm/dL

- Total bilirubin < 1.5 x ULN

- Creatinine < 1.5 x ULN

- Patient must have the capacity to understand and the willingness to sign a written
informed consent document.

- Patient must be able to tolerate MRIs. CT scans can NOT be substituted for MRI in this
study.

Exclusion Criteria:

- Recurrent malignant gliomas.

- Tumor foci detected below the tentorium or beyond the cranial vault.

- Allergy to gadolinium or contraindication to MRI scan.

- Patients who have received any form of brachytherapy or radiosurgery for their
glioblastoma prior to start of standard radiation.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PPX.

- Uncontrolled intercurrent illness including, but not limited to, hypertension 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.

- Pregnant women are excluded from this study. Because there is an unknown but potential
risk for adverse events in nursing infants secondary to treatment of the mother with
PPX, breastfeeding should be discontinued if the mother is treated with PPX.