Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

NCT01024907 | Completed Phase 1 DMC

• 2 other identifiers: UPCC 08309NCI-2009-01442
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Feasibility (phase I)

• Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)

  60 days (phase I) or 90 days (phase II) from completion of radiation therapy

Secondary Outcomes (6)

• Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)

• Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)

  Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months

• Cumulative total dose to normal brain tissue (phase II)

• Progression-free survival (phases I and II)

• Overall survival (phases I and II)

Study Arms (1)

Arm I

EXPERIMENTAL

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

Radiation: proton beam radiation therapy; Procedure: quality-of-life assessment; Other: questionnaire administration

Interventions

proton beam radiation therapy RADIATION

Undergo radiation

Arm I

quality-of-life assessment PROCEDURE

Ancillary study

Arm I

questionnaire administration OTHER

Ancillary study

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• WBC \>= 4000/mm\^3
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Maquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b.

  PMID: 23388559 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Astrocytoma; Ependymoma; Glioma; Oligodendroglioma; Pinealoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Robert Lustig

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: December 17, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)