A Study of Experimental Combination Therapy, Surgery With or Without Radiation Therapy for Mesothelioma

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Resectable Malignant Pleural Mesothelioma, Malignant Pleural Mesothelioma, Pleural Mesothelioma, Mesothelioma
Type: Drug study, Phase 1
Target:
28 Participants
Investigator:
Description
You are being asked to take part in this study because you have mesothelioma. People who are not in a study are usually treated with either drugs, and/or surgery, and/or radiation. One of the standard treatment options for your type of cancer is cisplatin and pemetrexed. Atezolizumab is an experimental cancer drug. It is approved for the treatment of patients with bladder cancer and lung cancer.

This study is being done to test the safety of giving all three drugs together. The study team will test any good and bad effects of taking atezolizumab after surgery and/or radiation. This study uses a combination of drugs (cisplatin, pemetrexed) that have already been FDA-approved. They will be given by vein.

The purpose of this study is to test the safety of giving one drug, atezolizumab, along with cisplatin and pemetrexed, before surgery. As well as giving atezolizumab after surgery by vein.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate
  1. Patient must be ≥18 years of age.
  2. Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to Step 1 registration.
  3. Patients requiring hearing aids or reporting hearing loss must have audiogram performed within 28 days prior to Step 1 registration. If audiogram is performed, patient must not have hearing impairment ≥ CTCAE Grade 2.
  4. Patient must have not had any major surgery or radiation within 28 days prior to Step 1 registration. Diagnostic thoracotomies and laparoscopies are not considered major surgeries.
  5. Patient must not have any anticancer therapy or investigational agent within 28 days prior to Step 1 registration.
  6. Patient must have adequate hematologic function defined as ANC ≥ 1,500/mcl, Hemoglobin ≥ 9 g/dl, and platelets ≥ 100,000/mcl documented within 28 days prior to Step 1 registration.
  7. Patient must have adequate kidney function defined as creatinine ≤ 1.5 x ULN and creatinine clearance ≥ 45ml/min documented within 28 days prior to Step 1 registration.
  8. Patient must have adequate liver function defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN within 28 days prior to Step 1 registration.
  9. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  10. Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
  11. Patient must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  12. Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
  13. Patient must not have severe infections within 28 days prior to Step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  14. Patient must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. This protocol includes an immunotherapy agent which can precipitate known autoimmune diseases.
  15. Patient must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  16. Patient must not have active tuberculosis.
  17. Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis. This protocol includes an immunotherapy agent which can precipitate known pneumonitis.
  18. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as evidenced by testing performed within 28 days prior to registration. Patients with past or resolved HBV infection are eligible. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test. Patient must not have active hepatitis C virus (HCV) infection as evidenced by testing performed within 28 days prior to registration. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test.
  19. Patient must NOT have a known positive test for HIV. Patients do not need to be screened for HIV. Patients with HIV are excluded due to a potential incompetent immune system and need for medications that could interfere with the treatment and immunotherapy.
  20. Patient must not have significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to initiation of treatment, unstable arrhythmias, or unstable angina given the higher risks associated with surgical resection.
  21. Patient must not receive live, attenuated influenza vaccine within 4 weeks prior to registration or at any time during the study and until 5 months after the last dose of atezolizumab.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will receive the cisplatin, pemetrexed, and atezolizumab once every 21 days for 4 cycles (one cycle is equivalent to 21 days). Then you will have surgery and possibly radiation treatments. After that, you will receive only atezolizumab once every 21 days for up to a year. After you finish atezolizumab treatment, your doctor will continue to watch you for side effects and follow your condition for three years.
Recruitment period
From May 30, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Biphasic Mesothelioma
  • Epithelioid Mesothelioma
  • Stage I Pleural Malignant Mesothelioma AJCC v7
  • Stage IA Pleural Malignant Mesothelioma AJCC v7
  • Stage IB Pleural Malignant Mesothelioma AJCC v7
  • Stage II Pleural Malignant Mesothelioma AJCC v7
  • Stage III Pleural Malignant Mesothelioma AJCC v7

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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