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BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain Tumor

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Trial Information

BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.


To evaluate the safety/tolerability and potential antitumor activity of PPX in combination
with temozolomide and radiation for patients with newly diagnosed brain tumors.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response by MRI

Outcome Time Frame:

30 days after completed treatment

Safety Issue:

No

Principal Investigator

Howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BrUOG

Authority:

United States: Food and Drug Administration

Study ID:

BrUOG-Brain-223

NCT ID:

NCT00763750

Start Date:

October 2008

Completion Date:

July 2012

Related Keywords:

  • Brain Tumor
  • glioblastoma multiforme or anaplastic glioma
  • Brain Neoplasms

Name

Location

Lifespan HospitalsProvidence, Rhode Island  02903