Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Low Dose Granulocyte-Macrophage Colony Stimulating Factor, in Patients With Progressive and/or Refractory Solid Malignancies

Study Name
Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Low Dose Granulocyte-Macrophage Colony Stimulating Factor, in Patients With Progressive and/or Refractory Solid Malignancies
ClinicalTrials.gov Identifier (if applicable)
KIROVAX003 NCT02224599
KIROVAX004 NCT02705703
Study Center
Institution Name
Oncology San Antonio
Institution Address
9102 Floyd Curl Drive
City
San Antonio
State
Texas
Zip Code
78240
Phone
(210) 616-9922
Website
http://www.oncologysa.com/
Study Contacts
Principal Investigator
Zulfi Jaffar, MD
P.I. Phone
(210) 616-9922
P.I. Email
zjaffar@oncologysa.com
Study Coordinator
Rosalinda Ferniz, MSN, RN, CNL-BC
Study Coordinator Phone
(210) 842-2147
Study Coordinator Email
rferniz@kiromic.com
OVERVIEW – in layman’s terms (150 words max)
Patients with progressive liver cancer, including cholangiocarcinoma patients, who have failed chemotherapy treatments and have run out options, may be potential candidates for this Phase I/II study.  Study patients will need to meet certain criteria before enrolling into the study.  The study patient will have their blood analyzed for specific tumor antigens.  Once the tumor antigens are identified, six vaccines are made specifically for the patient to be given once every 14 days with five days of another shot that helps the white blood cell count increase.  The vaccine and the white blood cell shot work together to help the body fight against the cancer cells to increase the chance to cure liver cancer.
Enrollment
July 24, 2017
Study Start Date
07/28/2017
Estimated Completion Date
01/31/2019
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To use the patients’ own immune system to trigger cancer cell death.
Inclusion Criteria – Patients Must:
  • Be able to provide informed consent
  • Be 18 years of age or older with histologically proven, progressive and/or refractory solid malignancy without available and potentially curative therapeutic options will be eligible for participation
  • Have presence of measurable or evaluable disease
  • Be willing to provide at least 250ml, and up to 500ml, of whole blood obtained by phlebotomy and/or consent to leukapheresis for dendritic cell generation
  • Have adequate renal function: creatinine < 2.0 mg/dl; hepatic function: bilirubin < 2.0 mg/dl; AST/ALT < 4 times the upper limit of normal range
  • Have adequate hematologic functions: CBC w/diff – platelets > 60,000/mm3; Hgb > 10.0 g/dl; lymphocytes > 1,000/mm3; neutrophils > 750/mm3
  • Karnofsky Performance Status > 70%.
  • Have an expected survival > 6 months
  • Demonstrate HLA-A1 restriction
  • Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more methods of birth control during the entire study and for 3 months after completing the study. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process. Another choice is for the patient’s sex partner to use one type of birth control methods.
Exclusion Criteria – Patients Must NOT:
  • Have received cytotoxic therapy (including endocrine and biological agents), radiation therapy, immunotherapy or non-topical steroids, w/n three (3) to four (4) weeks of enrollment
  • Have active immunosuppressive therapy (excluding topical steroids) for any other condition
  • Have persistent fever (> 24 hours) documented by repeated measurement or active uncontrolled infection w/n 4 weeks of enrollment
  • Have active ischemic heart disease or history of myocardial infarction w/n 6 months
  • Have active autoimmune disease, including, but not limited to: Systemic Lupus Erythematosus (SLE); Multiple Sclerosis (MS); Ankylosing Spondylitis (AS); Inflammatory Bowel Disease (IBD); Rheumatoid Arthritis (RA)
  • Be pregnant or breast feeding
  • Have an active second invasive malignancy, other than basal cell carcinoma of the skin
  • Have any contraindications or be allergic to cyclophosphamide and/or GM-CSF
  • Have received an organ transplant
  • Have any psychological or geographic conditions that prevent adequate follow-up or compliance with the study protocol
  • Have a diagnosis w/primary CNS or w/CNS metastases/involvement, or at any time during the disease course (patient will be removed from the study)
  • Patients without HLA-A1 restriction
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Blood testing to rule out HIV, Hepatitis A, B, and C; a special blood called HLA-A1; and women need to take a urine pregnancy test.
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Very low chance of having an allergic reaction from the treatments; from injections-slight fever, local injection irritation, rash, fatigue, or skin infections

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