Trial Search Results

Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

This pilot phase I/II trial studies the side effects and best dose of plerixafor after radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor after radiation therapy and temozolomide may be an effective treatment for high grade glioma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Radiation: radiation therapy
  • Drug: temozolomide
  • Drug: plerixafor
  • Other: laboratory biomarker analysis
  • Other: pharmacological study

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Patients must have tissue confirmation of high grade (WHO Grade IV) glioma including
   but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial
   features, glioblastoma with PNET features.

   - The patient must have post-operative contrast enhanced imaging (CT or MRI) unless only
   biopsy performed (in which case post-operative imaging is not routinely obtained. In
   these patients, 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 chemoradiation as specified in the
   protocol.

   - For those patients in which steroids are clinically indicated, there must be a stable
   or decreasing dose of steroid medication for ≥ one week prior to the start of
   infusion.

   - Patients must be between the ages of 18 and 75 years old.

   - Patients must have Karnofsky Performance score ≥ 60.

   - Adequate organ function is needed at time of screening visit including:

      - ANC ≥ 1500

      - Platelets ≥ 100,000 ml

      - Serum Creatinine ≤ 1.5mg/dl; Cr Clearance should be >50 mL/min

      - AST and ALT ≤ 3 times the upper limit of normal

      - If female of childbearing potential, negative pregnancy test

   - 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
   or arrhythmia

   - Prior malignancy except previously diagnosed and definitively treated more than 3
   years prior to trial or whose prognosis is deemed good enough to not warrant
   surveillance

   - Prior sensitivity to Plerixafor

   - Pregnant or patients who are breastfeeding

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sophie Bertrand
650-723-4467
Recruiting