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CASE 1312   |   12-344
A Phase II Evaluation of TRC105 in the treatment of recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)

Disease(s)
Brain
Hospital(s)
Main Campus
Phase(s)
Phase 2
Stage(s)
N/A
Type(s)
Therapeutic
Drug(s)
TRC105

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description
  1. Primary
    • Determine median overall survival in patients with recurrent or progressive GBM who have progressed on bevacizumab.
  2. Secondary
    • Assess safety and tolerability of TRC105 when given with bevacizumab by CTCAE version 4.0.
    • Determine objective response rate (ORR) by modified RANO criteria.
    • Determine the rate of progression free survival at 6 months (PFS-6).
    • Determine median time to progression.
    • Explore associations between clinical outcome and soluble angiogenic biomarkers including but not limited to VEGF, PDGF and TGF-B

Inclusion Criteria
  1. Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
  2. Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma or other grade IV malignant glioma (the patient must be on bevacizumab at the time of last progression).
  3. Patients with up to 3 prior recurrences are allowed.
  4. Karnofsky performance status ≥ 70%.
  5. Age ≥ 18 years old.
  6. Patients must have the following laboratory values:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Hemoglobin (Hgb) > 9 g/dL
    • Serum total bilirubin: ≤ 1.5 x ULN
    • ALT and AST ≤ 3.0 x ULN
    • Serum creatinine ≤ 1.5 x ULN
    • Blood coagulation parameters: INR ≤ 1.5
  7. Minimum interval since completion of radiation treatment is 12 weeks.
  8. Minimum interval since last drug therapy:
    • 2 weeks since last non-cytotoxic therapy
    • 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen
    • 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen.
  9. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  10. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant. Female patients of child-bearing potential must have a negative pregnancy test.
  11. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
  12. Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment.
  13. Patients must have a Mini Mental State Exam score ≥ 15.

Exclusion Criteria
  1. Patients who have had previous treatment with TRC105.
  2. Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  3. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • History or presence of serious uncontrolled ventricular arrhythmias
    • Clinically significant resting bradycardia
    • Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
    • Uncontrolled hypertension (defined by a SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg while on anti-hypertensive medications)
  4. Patients with cirrhosis, or active viral or nonviral hepatitis.
  5. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
  6. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
  7. Pregnant or breast-feeding women
  8. Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human, chimeric, or humanized antibodies.
  9. Patients with active bleeding or pathologic conditions that carry a high risk of bleeding, (i.e. hereditary hemorrhagic telangiectasia).
  10. Patients who are currently receiving anticoagulation treatment
  11. Patients unwilling or unable to comply with the protocol

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