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Brain Clinical Trials

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RTOG 3508/AbbVie M13-813

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT 414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Nicole Kern, BS
    484-503-4154

    Nicole.kern@sluhn.org
  • Treatment Agent: ABT-414

    Synopsis: The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.

    The study also plans to assess:
    ● The safety of ABT-414
    ● How your body handles this new drug with the combination

     

     

  • 1. Must have a clinical diagnosis of Glioblastoma (GBM)
    2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue
    3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100.
    4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
    5. Must have adequate bone marrow, renal, and hepatic function

     

  • 1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri
    2. Prior chemo therapy or radiosensitizer for head and neck cancer.
    3. Prior radiotherapy to the head or neck in overlap of radiation fields.
    4. Prior therapy for glioblastoma or other invasive malignancy.
    5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Mount Sinai Beth Israel

A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Nicole Kern, BS
    484-503-4154

    Nicole.kern@sluhn.org
  • Treatment Agent: 5-ALA (Gliolan®)

    Synopsis: The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) (Gliolan is the name brand for 5-ALA) for identifying your tumor during surgery. Gliolan® (5-ALA) is not FDA approved at this time. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, Gliolan® (5-ALA) can make the tumors glow red under blue light. This may make it easier for your doctor to visualize the tumor from your brain and is known as fluorescence-guided surgery. In multiple studies, Gliolan® (5-ALA)-induced tissue fluorescence has been shown to correlate with malignant tumor. The purpose of this study is to:

    • to study if Gliolan® (5-ALA) can predict the presence of tumor during the surgery for tumor resection (surgical removal of tumor).
    • confirm Gliolan® (5-ALA) is safe to use with minimal or no side-effects.

    During surgical resection of your brain tumor with fluorescence-guidance, after administration of Gliolan, multiple different portions of your brain tumor will be sampled and studied further after tissue banking at the Icahn School of Medicine at Mount Sinai. In addition to standard pathologic examination, the tumor samplings will be studied further for various genetic and protein expression changes localized to different regions of your tumor.

    You may qualify to take part in this research study because you may have a brain tumor type that may be visualized in the operating room by fluorescence-guidance after Gliolan® (5-ALA) administration. The manufacturer of the 5-ALA is Photonamic Inc., which is based in Germany and supplies the Gliolan® (5-ALA) to St. Luke’s University Health Network.

    The study also plans to assess:
    ● The safety of ABT-414
    ● How your body handles this new drug with the combination

    • Subjects included must have an MRI documenting a primary brain tumor for which resection is indicated and has been planned. These patients will include those with newly diagnosed or recurrent malignant gliomas. Standard criteria for diagnosis will include a distinct ring-like pattern of contrast enhancement with thick irregular walls on MRI for patients with a presumed newly diagnosed malignant glioma.
    • Age 18-80.
    • Karnofsky > 60%.
    • Subjects must have normal organ and marrow function as defined below:

    Leukocytes >3,000/mL Platelets >100,000/mL Total bilirubin below upper limit of normal AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal Creatinine below upper limit of normal OR Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

    • The effects of 5-aminolevulinic Acid (5-ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A pregnancy test will be performed for all women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    • Ability to understand and the willingness to sign a written informed consent document. Translation will be provided as appropriate by institution.
    • Inclusion of Women and Minorities: Both men and women and members of all ethnic groups are eligible for this trial.
    • Patients with radiographic tumors of, or involving, nonresectable midline, the basal ganglia, or brain stem as assessed by MRI.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 h.
    • Personal or family history of porphyria.
    • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. . Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-aminolevulinic acid (5-ALA), breastfeeding should be discontinued if the mother is treated with 5-aminolevulinic acid (5-ALA).
    • Women who are pregnant will be excluded from the trial as aminolevulinic acid (ALA) is unknown to be teratogenic or have abortifacient effects Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.

NCCTG N0577

Phase III Intergroup Study of Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Nicole Kern, BS
    484-503-4154

    Nicole.kern@sluhn.org
  • Treatment Agent: Temozolomide, radiotherapy, PCV chemotherapy

    Synopsis: The purpose of this study is to see if you have a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing parts of chromosomes are called a “tumor marker” as they make the tumor distinct from other kinds of tumors. This tumor marker is called the 1p/19q co-deletion. Tumors with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma. Standard therapy at this point in time is surgery followed by radiation therapy.

    Another purpose of this study is to see if patients survive for a longer period of time without the tumor progressing if they are treated with temozolomide alone as compared to radiotherapy with temozolomide chemotherapy or radiotherapy with PCV chemotherapy (Procarbazine, CCNU and Vincristine, which are the drugs that are used in this chemotherapy treatment, also known as PCV).

    • Age ≥ 18 years
    • Newly diagnosed and ≤ 3 months from surgical diagnosis
    • Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III], as determined by pre-registration central pathology review. Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q.
    • Tumor is co-deleted for 1p and 19q.
    • Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration. Patient must have recovered from the effects of surgery.
    • The following laboratory values obtained ≤ 21 days prior to registration.
      • Absolute neutrophil count (ANC) ≥ 1500/mm^3
      • Platelet (PLTs) count ≥ 100,000/mm^3
      • Hemoglobin (Hgb) > 9.0g/dL
      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
      • Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x ULN
      • Creatinine ≤ 1.5 x ULN
    • Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only.
    • Willing and able to complete neurocognitive testing without assistance and the Quality of Life (QOL) questionnaires with or without assistance
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Provide informed written consent.
    • Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (ie, active treatment and observation portion of the study)
    • Mandatory Tissue Samples for Correlative Research - Patient is willing to provide tissue samples for correlative research purposes
    • Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.
    • Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.
    • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
    • Concomitant serious immunocompromised status (other than that related to concomitant steroids).
    • Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
    • Other active malignancy within 5 years of registration. Exceptions:
      • Non-melanotic skin cancer or carcinoma in situ of the cervix. Note: if there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
    • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
    • Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.