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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763750
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : December 16, 2013
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Rhode Island Hospital
Maine Medical Center Research Institute
Information provided by (Responsible Party):
howard safran, Brown University

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: PPX +TMZ+XRT Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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 Name: PPX TMZ




Primary Outcome Measures :
  1. Number of Patients Assessed for Toxicity According to CTC Version 3.0 [ Time Frame: Throughout the entire study until patient is removed from study an average of 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763750


Locations
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United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
howard safran
Rhode Island Hospital
Maine Medical Center Research Institute
Investigators
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Principal Investigator: Howard Safran, MD BrUOG
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Responsible Party: howard safran, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00763750    
Other Study ID Numbers: BrUOG-Brain-223
First Posted: October 1, 2008    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by howard safran, Brown University:
glioblastoma multiforme or anaplastic glioma
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases