January 18, 2022 Brain

Protocol – Alliance A071401

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA   A071401

Pre-Registration:

  1. Local diagnosis of meningioma and have tissue available for central path review and integral biomarker testing.

Registration Eligibility:

  1. Presence of specific SMO/PTCH1, NF2 or AKT1/PIK3CA./CDK pathway mutations.
  2. Progressive or residual disease.
  3. Measurable disease as defined by a bi-dimensionally measurable.
  4. Target lesion on MRI brain or CT head images (MRI preferred).
  5. No chemotherapy, other investigational agents within 28 days of study treatment.
  6. No other concurrent investigational agents or other meningioma directed therapy (chemotherapy, radiation)
  7. Greater than 24 weeks must have elapsed from completion of radiation treatment (XRT, brachytherapy, radiosurgery) to registration.
  8. Steroid dosing stable for at least 4 days prior to registration.
  9. ECOG Performance Status 0-2.
  10. Stable for lesions for 6 months for patients with history of NF.
  11. No metastatic meningiomas.
  12. No history of allergic reactions attributed to compounds of similar biologic composition to assigned study drug.


January 18, 2022 Brain

Protocol – NRG-BN007

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA  NRG-BN007

Prior to Step 1 Registration:

  1. No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation is the tumor on local or other testing are ineligible and should not be registered).
  2. Availability of FFPE tumor tissue block and H&E stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status.
  3. Contrast enhanced brain MRI within 3 days after surgery.

Prior to Step 2 Registration:

  1. Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review.
  2. MGMT promoter without methylation confirmed by central pathology review.  NOTE: Patients with tissue that is insufficient or inadequate for analysis fails MGMT testing, or has indeterminate or methylated MGMT promoter are excluded.
  3. IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and not mutation must be fount (i.e. IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2)
  4. History and physical exam within 28 days prior to Step 2 Registration.
  5. Karnofsky Performance Status greater or equal to 70 within 28 days prior to Step 2 registration.

Ineligibility:

  1. Prior therapy for tumor except for resection.  For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is prior Laser interstitial thermal therapy, Gliadel wafer, radiotherapy, readiosurgery, gamma knife, cyber knife, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery.
  2. Current of planned treatment with any other investigational agents for the study cancer.
  3. Definitive clinical or radiologic evidence of metastatic disease outside the brain.
  4. Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years.
  5. Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields.


February 23, 2021 Brain

Protocol – Alliance A071702

Please Note Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility.

Eligibility:

SCHEMA  A071702

Pre-Registration:

  1. Histologically-confirmed glioblastoma presenting at first or second recurrence including secondary glioblastoma.
  2. Presence of measurable, as defined by a bidimensionally measurable lesion on MRI with a minimum diameter of 10mm in both dimensions, prior to resection or biopsy of recurrent tumor.
  3. Tissue available from surgical resection or biopsy of recurrent tumor less than or equal to 28 days prior to pre-registration or planned surgery or biopsy of recurrent tumor less than or equal to 28 days after pre-registration.
  4. Does not require greater than 4 mg dexamethasone daily beyond the perioperative period defined as the less than or equal to 2 weeks after surgical procedure.
  5. No active autoimmune disease or history of autoimmune disease.
  6. No prior treatment with checkpoint blockage therapies or bevacizumab.
  7. No prior treatment with laser ablation at the time of recurrent tumor tissue sampling. Patients who have previously undergone laser ablation greater than or equal to 4 months prior to recurrent tumor tissue sampling can be included.
  8. Must be at least 18 years of age.
  9. ECOG performance status 0-2.
  10. Adequate marrow and organ function.
  11. Able to undergo brain MRI with contrast


February 22, 2021 Brain

 Protocol – Alliance – A071701

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

SCHEMA  A071701

Pre-Eligibility:

  1. Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If the patient does not have any evidence of extracranial disease, or if there is insufficient extracranial tissue for profiling, brain metastasis tissue is sufficient for eligibility.

Registration:

  1. Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease.
  2. New or progressive brain metastases.
  3. Measurable CNS disease.
  4. Ability to obtain MRIs with contrast.
  5. No surgery within 2 weeks prior to or after registration.
  6. No chemotherapy within 14 days prior to registration.
  7. Presence of clinically actionable alteration in NTRK, ROSI, or CDK pathway or P13K in both a brain metastasis and extracranial site per central review.
  8. Must be at least 18 years of age.
  9. No uncontrolled medical comorbidities per investigator discretion.
  10. Radiation to symptomatic non-target sites within neural axis is allowed prior to registration without washout.

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