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Colorectal Cancer-GVAX - Healing Genes
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Colorectal Cancer-GVAX

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GVAX for Colorectal Cancer

A Pilot Safety Study of Vaccination With Autologous, Lethally Irradiated Colorectal Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor


Phase 1

DESCRIPTION:

Doctors at Massachusetts General Hospital seek patients with colorectal cancer with liver metastases to trial therapeutic, autologous (to the self), gene-modified vaccines. The vaccines are cells taken from the patient’s tumor, gene-modified to produce an anti-tumor protein that stimulates the immune system to attack the cancer, then injected back to the patient.

Study participants will receive up to 6 injections of the vaccine after it is made from their tumor cells, then be followed for 2 to 10 years.


PATIENT MUST:

  • Be 18 years of age or older
  • Not have active autoimmune disease
  • Be at least 4 weeks since last dose of chemotherapy, radiotherapy, immunotherapy, systemic glucocorticoid therapy or operation in order to receive vaccine
  • Not have hepatic metastases involving both branches of the portal vein or all three hepatic veins

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Recovery of tumor cells and genetic modification in the lab to prepare vaccine therapy.
  3. Intravenous injections will be scheduled, 6 in total.
  4. Follow up will continue for 2 to 10 years including physical, lab, and overall survival assessments.

LOCATIONS & CONTACTS:
The study location is at Massachusetts General Hospital in Boston, MA, Map.
Contact: Cristina Ferrone, MD  |  6176436189  |  [email protected]
 
SPONSORS
Massachusetts General Hospital
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT01952730

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