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Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

Study Purpose

This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.

Recruitment Criteria

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

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.
  • - The patient must have post-operative contrast enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) unless only biopsy performed.
For patients having biopsy alone, post-operative imaging is not routinely obtained and therefore the preoperative study will serve as baseline.
  • - Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.
  • - Patients must have Karnofsky performance score >= 60.
  • - Absolute neutrophil count (ANC) >= 1500 (at time of screening).
  • - Platelets >= 100,000 ml (at time of screening).
  • - Serum creatinine =< 1.5mg/dl (at time of screening).
  • - Creatinine (Cr) clearance should be > 50 mL/min (at time of screening).
  • - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal (at time of screening).
  • - If female of childbearing potential, negative pregnancy test (at time of screening).
  • - The patient or his/her legal representative must have the ability to understand and willingness to sign a written informed consent document.
  • - Patient agrees to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 3 months following the plerixafor infusion.

Exclusion Criteria:

  • - Prior or concurrent treatment with Avastin (bevacizumab).
  • - Prior exposure to plerixafor.
  • - Prior use of other investigational agents to treat the brain tumor.
  • - Recent history of myocardial infarct (less than 3 months) or history of active angina.
  • - Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
  • - Prior sensitivity to plerixafor.
  • - Pregnant or patients who are breastfeeding.

Trial Details

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.

Trial ID:
NCT03746080

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.

Phase
Phase 2

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

Lead Sponsor
Lawrence Recht

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

Principal Investigator
Lawrence Recht
Principal Investigator Affiliation Stanford Cancer Institute Palo Alto

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

Agency Class
OtherIndustry
Overall Status Recruiting
Countries United States

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

Conditions
Glioblastoma, Glioblastoma With Primitive Neuronal Component, Gliosarcoma, Malignant Glioma, Oligodendroglial Component Present
Additional Details

PRIMARY OBJECTIVES:

  • I. To assess the 6 month progression-free survival (PFS) (post initiation of radiation) of continuous infusion plerixafor beginning one week prior to the end of concurrent chemotherapy with temozolomide and a modified radiation regimen that includes a component of whole brain radiation therapy (WBRT) in patients with newly diagnosed glioblastoma (GBM).
SECONDARY OBJECTIVES:
  • I. To assess the median survival of patients treated with continuous infusion plerixafor/WBRT.
  • II. To assess the toxicities both short and long term of continuous infusion plerixafor/WBRT.
  • III. To assess the patterns of failure (in and out of irradiated brain field, out of brain) of continuous infusion plerixafor/WBRT.
OUTLINE: After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1-42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days 1-28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6-12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for adverse events for 30 days after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up.

Contact a Trial Team

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Stanford Cancer Institute Palo Alto, Palo Alto, California

Status

Recruiting

Address

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

Site Contact

Lawrence Recht

lrecht@stanford.edu

650-725-8630

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