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Brain/Spinal Cord Cancers

PLX3397 + Radiation Therapy + Temozolomide for Newly Diagnosed Glioblastoma (20131088)
An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients with Newly Diagnosed Glioblastoma
Status Conditions Phase Study ID
Recruiting Astrocytomas; Brain Cancer; Glioblastoma Multiforme; Glioma; Solid Tumors Phase I/II 20131088
NCT01790503
Summary

The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).


Investigator
Marc Chamberlain, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Male or female patients ≥18 years old.
  • Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to screening. Tumor must have a supratentorial component. For all patients, availability of a surgical tumor block sufficient to generate at least 20 unstained slides.
  • The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
    1. A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to C1D1.
    2. Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
  • Patients must receive RT at the participating institution.
  • Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
  • Karnofsky performance status of ≥70.
  • Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb >10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN).
  • Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
Exclusions (conditions that would prevent participation in this study)
  • Evidence of recurrent GBM or metastases detected outside of the cranial vault.
  • Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
  • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
  • Prior radiation or chemotherapy for glioblastoma or glioma.
  • Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.
  • Prior allergic reaction to temozolomide.
  • History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage.
  • Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.
  • Previous hepatitis B or C infection.
  • Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug.
  • Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
  • Women of child-bearing potential who are pregnant or breast feeding.
  • At Screening QTcF ≥450 msec for males and ≥470 msec for females.
Last Updated
December 02, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.