A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-007402
    • Rochester, Minnesota: 15-007402
    Sponsor Protocol Number: 15-007402

About this study

This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigators Dr. Cohen and Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

 Eligibility:

  • Donors must be adult and less than 75 years old (age 21-74 acceptable). (It is not considered appropriate for minors to donate, as there is no direct medical benefit to the donors or to others from this procedure).   
  • Weight at least 90 pounds.
  • Despite their diagnosis of malignancy, the patient must currently be in underlying good health, defined as “feeling well and can perform normal activities” (ECOG performance status = 0 to 1).
  • No known symptomatic heart, lung, kidney disease, or bleeding disorders.
  • No history of engaging in high-risk activities for exposure to the AIDS virus including intravenous drug use, unprotected sex with multiple partners, or exposure to unsterile needles such as acupuncture or tattoo needles.
  • No history of AIDS or HTLV infection.
  • No history Hepatitis B or C seropositivity.
  • No history Infectious or Idiopathic hepatitis or unexplained jaundice.
  • Female subjects should not be pregnant.

Additional eligibility will include:

  • Adequate venous access for phlebotomy or previous placement of an indwelling venous catheter allowing removal of non hemolyzed blood
  • No history malaria, tuberculosis, syphillis, Lyme disease, Infectious mononucleosis, Epstein‑Barr syndrome, or Creuzfeld-Jacob disease.
  • If donor has an eligible chronic condition such as hypertension or psychiatric diagnosis, condition must be under treatment and/or under control in the estimation of the protocol’s physician investigators.
  • No hx of multiple primary cancers within the past 3 years other than removed non-melanoma skin cancer
  • No sexual contact or cohabitation with a person who has hepatitis within the past 12 months.
  • No detainment or incarceration within a facility (juvenile detention, lockup, jail, or prison) within the past 12 months.
  • No non-autologous transfusion of blood products within past 12 months.
  • No history of a human bite within past 12 months.
  • No history of exposure to HIV-infected fluids within past 12 months.
  • Must not be on the following medications currently:
  1. Clopidogrel (Plavix) or Ticlid (Ticlopidine)
  2. Coumadin (warfarin) , heparin or other prescription blood thinners
  3. Chronic doses of glucocorticoids more than twice physiologic (e.g., daily prednisone or prednisolone >10 mg daily, hydrocortisone >40 mg daily, or dexamethasone > 4 mg daily.
  • Must never have received human pituitary-derived growth hormone.
  • Willingness to disclose current medications.
  • Not currently on medications which in the opinion of the P.I. indicate that the donor is in an unsteady state of health (e.g., compensated allergies) or immunosuppressed (e.g., on supraphysiologic doses of steroids, unless the patient is receiving the steroid as a component of cancer chemotherapy).

No history of any of the following adverse reactions during any previous blood donation procedure:

  • --Anxiety in excess of Grade II (i.e. unresponsive to reassurance and medication required)
  • --Hypotension in excess of Grade II (i.e., unresolved by pausing the procedure, recumbency and fluid administration)
  • --Vasovagal reaction in excess of Grade II (i.e., unresolved by pausing the procedure, recumbency and fluid administration)
  • --Hematoma in excess of Grade II (i.e., progressive resolution failed to occur with local application of pressure)
  • --Pain at venous access site in excess of Grade II (i.e., pain persists beyond 48 hours)
  • --Infection: any occurrence unattributable to nursing error
  • --Air embolism: any occurrence
  • --Unanticipated adverse events: any occurrence
  • No other health issues which in the opinion of the Principal Investigator render an individual unsuitable for prospective phlebotomy donation.
  • No donation of whole blood or apheresis procedure within the past 21 days.
  • Not immunized (vaccinated) in past 4 weeks.    
  • No infection symptoms in past 10 days.
  • No antibiotics taken in past 10 days.
  • Aspirin doses greater than 100 mg daily may not be taken during the 48 hours prior to the blood collection or on the day of collection

Three cohorts of patients will be collected.:

  • Cohort 1 includes
    • Advanced unresectable pancreatic cancer
    • Advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive),
    • Advanced, unresectable colorectal cancer,
    • Advanced, unresectable ovarian cancer,
    • Advanced, unresectable clear cell kidney cancer,
    • Advanced, unresectable bladder cancer,
    • Advanced, unresectable lung adenocarcinoma,
    • Advanced, unresectable multiple myeloma. 
    • Also eligible are up to 6 donors with triple negative breast cancer and
    • Up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy).
  • Cohort 2 includes
    • (1) muCALR+ primary MF, and
    • (2) muCALR+ secondary MF.
  • Cohort 3 includes
    • (1) CMVpp65 absent and
    • (2) CMVpp65 present GBM..
    • Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection:
      • (1) prior to initiation of systemic therapy;
      • (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy;
      • (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy.
      • Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Peter Cohen, M.D.

Open for enrollment

Contact information:

Maybelline Doolan

(480)342-6084

Doolan.Maybelline@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Peter Cohen, M.D.

Contact us for the latest status

Contact information:

Yi Lin M.D., Ph.D.

(507)284-5096

Lin.Yi@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions