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Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Study Purpose

This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed primary glioblastoma multiforme (GBM) - Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide) - Patient must be diagnosed with recurrent GBM either with biopsy or radiographically.
  • - Karnofsky Performance Status (KPS) >= 70.
  • - Ability to understand and willingness to sign a written informed consent.
  • - If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment.
  • - For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)

    Exclusion Criteria:

    - Patients with active infection.
  • - Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times.
  • - Refusal to sign informed consent.
  • - Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment.
- Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02575027
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Tania Kaprealian
Principal Investigator Affiliation UCLA / Jonsson Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Recurrent Brain Neoplasm
Additional Details

PRIMARY OBJECTIVES:

  • I. To determine the accuracy of dose delivery and patient comfort with treatment time.
  • II. To evaluate normal tissue dose volume statistics and compare to standard planning.
OUTLINE: Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation. After completion of study treatment, patients are followed up at 6 weeks.

Arms & Interventions

Arms

Experimental: Treatment (4pi radiotherapy)

Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.

Interventions

Radiation: - Palliative Radiation Therapy

Undergo 4pi palliative radiotherapy

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Radiation Therapy Treatment Planning and Simulation

Undergo 4pi radiation simulation and planning

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

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