Trial Search Results

Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: cilengitide
  • Other: laboratory biomarker analysis
  • Other: pharmacological study

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed primary central nervous system (CNS) high-grade glioma,
   including any of the following:

      - Glioblastoma multiforme

      - Anaplastic astrocytoma

      - Anaplastic oligodendroglioma

      - High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma,
      anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)

         - No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord
         high-grade astrocytoma

      - Gliosarcoma

   - Recurrent or progressive disease that is refractory to standard therapy

   - Radiographically documented measurable disease

      - Lesion must be at least twice the thickness of the image from which it is derived
      (e.g., 10 mm for a 5 mm slice thickness)

   - No diffuse pontine gliomas

   - No evidence of prior CNS bleeding

   - Karnofsky performance status (PS) 50-100% (patients > 16 years of age)

   - Lansky PS 50-100% (patients =< 16 years of age)

   - Life expectancy >= 8 weeks

   - Absolute neutrophil count (ANC) >= 1,000/μL

   - Platelet count >= 100,000/μL (transfusion independent)

   - Hemoglobin >= 8.0 g/dL (red blood cell [RBC] transfusions allowed)

   - Creatinine clearance or radioisotope glomerular filtration rate >= 70mL/min OR serum
   creatinine based on age/gender as follows:

      - 0.4 mg/dL (1 month to < 6 months of age)

      - 0.5 mg/dL (6 months to < 1 year of age)

      - 0.6 mg/dL (1 to < 2 years of age)

      - 0.8 mg/dL (2 to < 6 years of age)

      - 1.0 mg/dL (6 to < 10 years of age)

      - 1.2 mg/dL (10 to < 13 years of age)

      - 1.5 mg/dL (male) or 1.4mg/dL (female) (13 to < 16 years of age)

      - 1.7 mg/dL (male) or 1.4mg/dL (female) (>= 16 years of age)

   - Total bilirubin =< 1.5 times upper limit of normal (ULN) for age

   - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times ULN
   for age

   - No evidence of dyspnea at rest

   - No exercise intolerance

   - Pulse oximetry > 94%, if determination is clinically indicated

   - Seizure disorder is allowed provided it is well-controlled with anticonvulsants

   - No uncontrolled infection

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - Recovered from all prior therapy

   - No more than two prior treatments for high-grade glioma (i.e., one initial treatment
   and one treatment for relapse)

   - More than 2 weeks since prior myelosuppressive chemotherapy (>= 6 weeks for
   nitrosoureas)

   - At least 1 week since prior non-myelosuppressive chemotherapy, immunotherapy, or
   biologic therapy

   - At least 2 weeks since prior local palliative radiotherapy (i.e., small port) to a
   symptomatic non-target lesion only

   - At least 3 months since prior craniospinal radiotherapy

   - At least 6 weeks since prior substantial bone marrow radiotherapy

   - At least 6 months since prior allogeneic stem cell transplant (SCT) or rescue

      - Patients who have undergone prior allogeneic SCT and who have graft-versus-host
      disease (GVHD) must have controlled GVHD that is =< grade 2

   - At least 1 month since prior autologous SCT

   - More than 1 week since prior growth factors (> 3 weeks for pegfilgrastim [Neulasta®])

   - No other concurrent anticancer therapy, including chemotherapy or immunomodulating
   agents

   - No other concurrent experimental agents or therapies

   - No concurrent alternative or complimentary therapies

   - No concurrent homeopathic medicines

   - No concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid
   (aspirin)

   - No concurrent steroids as anti-emetics

   - Concurrent steroids for treatment of increased intracranial pressure allowed if on a
   stable or decreasing dose for >= 1 week before study entry

   - Concurrent radiotherapy to localized painful lesions allowed provided >= 1 measurable
   lesion is not irradiated

Ages Eligible for Study

N/A - 21 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
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting