Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01024907
First received: December 2, 2009
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.


Condition Intervention Phase
Adult Brain Tumor
Adult Brain Stem Glioma
Adult Diffuse Astrocytoma
Adult Ependymoma
Adult Grade II Meningioma
Adult Melanocytic Lesion
Adult Meningeal Hemangiopericytoma
Adult Mixed Glioma
Adult Oligodendroglioma
Adult Pineal Gland Astrocytoma
Adult Pineocytoma
Recurrent Adult Brain Tumor
Radiation: proton beam radiation therapy
Procedure: quality-of-life assessment
Other: questionnaire administration
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proton Radiation for Low Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Feasibility (phase I) [ Designated as safety issue: No ]
  • Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II) [ Time Frame: 60 days (phase I) or 90 days (phase II) from completion of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II) [ Designated as safety issue: Yes ]
  • Fatigue as assessed by the Brief Fatigue Inventory (phases I and II) [ Time Frame: Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months ] [ Designated as safety issue: No ]
  • Cumulative total dose to normal brain tissue (phase II) [ Designated as safety issue: No ]
  • Progression-free survival (phases I and II) [ Designated as safety issue: No ]
  • Overall survival (phases I and II) [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: proton beam radiation therapy
Undergo radiation
Procedure: quality-of-life assessment
Ancillary study
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary study

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)

SECONDARY OBJECTIVES:

I. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI. To evaluate the incidence and severity of fatigue in low grade glioma treated with protons. (Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients treated for low grade glioma. (Phase II)

OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Patients with histologically confirmed diagnosis of low grade glioma of the CNS
  • Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
  • Patients must have a Karnofsky Performance Status of >= 60
  • Patients must be able to provide informed consent
  • Patients must have adequate bone marrow function:

    1. WBC >= 4000/mm^3
    2. platelets >= 100,000 mm^3
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc); Hysterectomy or menopause must be clinically documented

Exclusion

  • Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  • Patients with the following histologies:

gliomatosis cerebrei, WHO III or IV gliomas

  • Patients who have had any prior Radiation treatment
  • Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
  • Pregnant women, women planning to become pregnant and women that are nursing
  • Patients who are actively being treated on any other therapeutic research study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024907

Contacts
Contact: Robert Lustig, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robert Lustig    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Robert Lustig, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Robert Lustig Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Lustig, Robert, Abramson Cancer Center of The University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01024907     History of Changes
Other Study ID Numbers: UPCC 08309, NCI-2009-01442
Study First Received: December 2, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Meningioma
Astrocytoma
Brain Neoplasms
Ependymoma
Glioma
Hemangiopericytoma
Oligodendroglioma
Pinealoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014