Clinical Trials

 Eligibility:

• Donors must be adult and less than 74 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:
  • Clopidogrel (Plavix) or Ticlid (Ticlopidine);
  • Coumadin (warfarin) , heparin or other prescription blood thinners;
  • 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
  • muCALR+ primary MF; and
  • muCALR+ secondary MF.
• Cohort 3 includes
  • CMVpp65 absent; and
  • 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:
    • prior to initiation of systemic therapy;
    • 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;
    • 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.

Eligibility last updated 10/6/21. Questions regarding updates should be directed to the study team contact.