Cart

Cart


Research & Trial Information

SCHEMA A091401

Protocol #: A091401

Cancer Type: Sarcoma

Eligibility Criteria:

  1. Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review.
  2. Measurable disease.  Locally advanced/unresectable or metastatic disease.
  3. Prior Treatment• ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy.

    • No prior therapy with ipilimumab or nivolumab, or any agent targeting PD-1, PD-L1 or CTLA-4.

    • No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration. For GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment.

    • Patients should have resolution of any toxic effects of prior therapy

  4. No history of the following:• Active known or suspected autoimmune disease.

    • Patients with HIV are eligible if the lymphocytes > 350 CD4+ cells and no detectable viral load

    • Symptomatic, untreated, or uncontrolled brain metastases present.

    • Active autoimmune colitis

    • Autoimmune panhypopituitarism

    • Autoimmune adrenal insufficiency

    • Known active hepatitis B or C

  5. No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration.
  6. Age ≥ 18 years.
  7. ECOG Performance Status 0 or 1.

 



Research & Trial Information

SCHEMA A091304

Protocol #: A091304

Cancer Type: Sarcoma

Eligibility Criteria:

  1. Eligible patients must have histopathologically confirmed sarcoma.
  2. Locally advanced or metastatic disease. Locally advanced disease is defined as disease not amenable to local therapy such as surgery and/or radiation.
  3. Measurable disease.
  4. Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease. Prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment.There is no limit to the number of prior lines of treatment a patient has received. No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration. No treatment with radiation therapy ≤ 28 days before study registration. Patients should have resolution of any toxic effects of prior therapy. Prior treatment with pazopanib or any PI3K, mTOR, AKT, or dual PI3K/mTOR complex (TORC1/TORC2) inhibitors will be prohibited.
  5.  Age ≥ 18 years.
  6. ECOG Performance Status ≤ 1.
  7. Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study.
  8. Patient history: patients who have any of the following are NOT eligible: CNS: Symptomatic, untreated, or uncontrolled brain metastases present. Heme: Active bleeding or bleeding diathesis. Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration. Acute GI bleed within 28 days of registration. Diabetes Mellitus. Cardiac and Vascular Disorders.
  9. Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study.
  10. Chronic concomitant treatment with strong inhibitors of CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.’
  11. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

 

 


Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium

Newsletter

Ⓒ 2018 Genesys Hurley Cancer Institute | All Rights Reserved.

Cart

Cart