Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine (MAPSS)

Overview

Multiple myeloma patients will receive a cancer vaccine, called TXSVN that has been derived from the bacteria Salmonella. TXSVN is a weakened form of a live vaccine strain of the Salmonella bacteria (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce a protein known as Survivin that stimulates an immune response in the body to the Survivin tumor antigen. CVD908ssb has been administered to over 80 healthy donors as a Salmonella vaccine in reported clinical trials. This trial intends to explore administration of this vaccine at a lower dose than what was tested in healthy individuals.

Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin.

TXSVN may activate the immune system which is your body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports.

TXSVN, the modified strain of CVD908ssb has not been tested in humans to this date. TXSVN is an investigational product not approved by the U.S. Food and Drug Administration.

The purpose of this study is to find the largest safe dose of TXSVN, to learn what the side effects are, and to see whether this therapy might help participants with multiple myeloma.

SparkCures ID 1176
Trial Phase Phase 1
Enrollment 24 Patients
Treatments
  • CVD908ssb-TXSVN
Tags
Trial Sponsors
  • Baylor College of Medicine
Trial Collaborators
  • Methodist Hospital
NCT Identifier

NCT03762291

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Any patient, ≥ 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least two lines of conventional therapy which can include an autologous HSCT. If a patient has received an autologous or syngeneic SCT they must be > 90 days post-transplant
  • Patients with life expectancy ≥ 6 weeks.
  • Pulse oximetry of > 90% on room air in patients who previously received radiation therapy to the chest. This is not required in patients who have not received radiation therapy to the chest in the past.
  • Patients with a Karnofsky score of ≥ 50
  • Patients with bilirubin ≤ 2x upper limit of normal, AST ≤ 3x upper limit of normal, and Hgb > 8.0 (transfusion allowed - see Section 7.3).
  • ANC > 1000 at the time of vaccination and an ALC > 500.
  • Patients with a creatinine ≤ 2x upper limit of normal for age.
  • Patients should have been off other investigational therapy for one month prior to entry in this study.
  • Patients should be off anti-bacterial therapy for 14 days prior to vaccination
  • Patients should have been off conventional therapy for at least 1 week prior to entry in this study except immunomodulator drugs
  • Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent.
  • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
  • Ability to swallow medications

Exclusion Criteria:

  • Severe intercurrent infection.
  • Patients receiving >0.5 mg/kg/day (prednisone equivalent) of systemic corticosteroids
  • Pregnant or breast feeding.
  • Grade II or higher nausea, vomiting or diarrhea.
  • History of allergy to prior vaccination with a Salmonella vaccine
  • HIV infection
  • Unable to tolerate Salmonella directed antibiotics
  • Household contacts who are immunocompromised, pregnant or under 2 years of age.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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