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Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

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Trial Information

Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer


STUDY EVALUATIONS

- Pre-Vaccination

- Complete physical examination (with ECOG performance status (PS), medical history,
weight, height, and BSA); the exact size and location of all tumor lesions will be
noted in the flow sheet, documented in the text note, and by photographic and/or
radiologic means

- CEA levels in the blood (as a tumor marker)

- Women of childbearing potential will have a serum beta-HCG pregnancy test

- Anti-HIV, HbsAg and Anti-HCV

- CBC, platelet, differential

- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium,
potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST,
ALT, total bilirubin

- PT/PTT testing

- Electrocardiogram (EKG), if indicated

- Radiologic imaging to evaluate the status of disease may be performed as a part of
routine care.

- Leukapheresis

- Dendritic cell vaccine preparation

- Procedures during priming vaccination (Days 1 to 3)

- Complete physical examination (with PS and weight)

- 19F/1H MRI scanning on day of vaccination, 6 hrs (±1 hour) and 24 hrs (±4 hour)
post-injection.

- Blood for in vitro assays, before first i.d. administration on day 1 (baseline)
and after the last i.d. administration on day 3

- DTH tests: administration on day 1 and readout on day 3

- Biopsy of the DTH site can be performed in any subject who consented to such
biopsy, at the discretion of the investigator/sub-investigator (Day 3 only, based
on readout)

- Procedures on Day 15

- Complete physical examination (with ECOG PS and weight)

- CBC, platelet, differential

- Blood for in vitro assays

- Procedures during booster courses (Days 36 to 38, 64 to 66, and 91 to 93)

- Complete physical examination (with PS and weight) on the 1st day of each 3 day
course (Days 36, 64, and 91)

- CBC, platelet, differential on the 1st day of each 3 day course (Days 36, 64, and
91)

- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium,
potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST,
ALT, total bilirubin on the 1st day of each 3 day course (Days 36, 64, and 91)

- DTH tests: administration on 1st day and readout on 3rd day during 2nd and 3rd
booster courses (Administration days 64 and 91, readout days 66 and 93)

- Biopsy of the DTH site can be performed in any subject who consented to such
biopsy, at the discretion of the investigator/sub-investigator (3rd day of 3 day
course, based on readout of DTH test)

- Blood for in vitro assays (1st and 3rd day of each 3 day course)

- Procedures on Day 105

- Complete physical examination (with ECOG PS and weight)

- CEA levels in the blood (as a tumor marker)

- CBC, platelet, differential

- Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium,
potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST,
ALT, total bilirubin

- Radiologic imaging to evaluate the status of disease may be performed as a part of
routine care

- Photography

- Long term follow-up The subjects with lack of disease progression at 6 months after the
last vaccination will be monitored for the disease free survival and overall survival.
Subjects may be contacted every 3 months within the first three years after study
intervention, every six months until year 5, and annually afterwards. In lieu of direct
contact a medical record review may be performed to obtain the data for these time
points for disease progression and/or survival.


Inclusion Criteria:



- Subjects must have adequate tumor tissue from surgery, performed as part of their
conventional care.

- No chemotherapy, radiotherapy, major surgery, or biologic therapy for their
malignancy in the 2 weeks prior to vaccine administration and they must have
recovered from all side effects.

- An ECOG performance status of 0, 1, or 2.

- Age equal to 18 years or older.

- Blood tests:

- Platelet counts greater than 100,000 (platelet count, hematocrit, and WBC will
be re-evaluated before leukapheresis, within 2 weeks)

- Hematocrit > 27.0

- White blood count > 2000/µL

- Creatinine less than or equal to 2 X ULN

- Aware of the neoplastic nature of his/her illness, the experimental nature of the
study intervention, alternative treatments, potential benefits and risks, and willing
to sign a written informed consent document.

Exclusion Criteria:

- Subjects currently treated with systemic immunosuppressive agents, including
steroids, are ineligible until 2 weeks after removal from immunosuppressive
treatment. Subjects on maintenance steroids because of adrenal insufficiency are
eligible.

- Subjects with total bilirubin greater than 2 X ULN.

- Subjects with uncontrolled pain.

- Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV.
(Hypothyroidism is allowed.)

- Subjects who are allergic to or develop an allergy to heparin.

- Subjects who are pregnant.

- Subjects who have sensitivity to drugs that provide local anesthesia.

- Subjects who have medical contraindications for MRI. Such contraindications include:

- Electrical implants such as cardiac pacemakers or perfusion pumps

- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,
artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos
near the eye or steel implants

- Ferromagnetic objects such as jewelry or metal clips in clothing

- Pre-existing medical conditions, including claustrophobic reactions, the
likelihood of developing a seizure or any greater than normal potential for
cardiac arrest

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events from the labeled DC vaccine

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

David L. Bartlett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

10-052

NCT ID:

NCT01671592

Start Date:

January 2013

Completion Date:

January 2014

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
  • Cancer
  • colorectal
  • tumor
  • neoplasms
  • carcinoma
  • vaccine
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

UPMC Hillman Cancer CenterPittsburgh, Pennsylvania  15232