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

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.

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor
• Intervention / Treatment: Drug: PPX +TMZ+XRT

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Lifespan Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPX +TMZ+XRT; XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36	Drug: PPX +TMZ+XRT; PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays); Other Names: PPX TMZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients Assessed for Toxicity According to CTC Version 3.0	Throughout the entire study until patient is removed from study an average of 6 weeks

Collaborators and Investigators

• Sponsor: howard safran
• Collaborators: Rhode Island Hospital; MaineHealth
• Investigators: Principal Investigator: Howard Safran, MD, BrUOG

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: glioblastoma multiforme or anaplastic glioma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: BrUOG-Brain-223