deltatrials
Completed PHASE1 NCT00028496

Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas

Sponsor: National Cancer Institute (NCI)

Conditions Adenocarcinoma of the Colon Adenocarcinoma of the Gallbladder Adenocarcinoma of the Pancreas Adenocarcinoma of the Rectum Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Cholangiocarcinoma of the Gallbladder Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Male Breast Cancer Mixed Adenocarcinoma of the Stomach Ovarian Endometrioid Adenocarcinoma Paget Disease of the Breast With Intraductal Carcinoma Paget Disease of the Breast With Invasive Ductal Carcinoma Recurrent Adult Primary Liver Cancer Recurrent Breast Cancer Recurrent Colon Cancer Recurrent Gallbladder Cancer Recurrent Gastric Cancer Recurrent Malignant Testicular Germ Cell Tumor Recurrent Pancreatic Cancer Recurrent Rectal Cancer Recurrent Salivary Gland Cancer Salivary Gland Adenocarcinoma Stage II Malignant Testicular Germ Cell Tumor Stage II Pancreatic Cancer Stage III Colon Cancer Stage III Gastric Cancer Stage III Malignant Testicular Germ Cell Tumor Stage III Pancreatic Cancer Stage III Rectal Cancer Stage III Salivary Gland Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IV Breast Cancer Stage IV Colon Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer Stage IV Rectal Cancer Stage IV Salivary Gland Cancer Thyroid Gland Medullary Carcinoma Unresectable Gallbladder Cancer
Interventions recombinant fowlpox GM-CSF vaccine adjuvant recombinant fowlpox-CEA(6D)/TRICOM vaccine sargramostim
Updated 6 times since 2017 Last updated: Jan 24, 2013 Started: Nov 30, 2001 Primary completion: Nov 30, 2005

Listed as NCT00028496, this PHASE1 trial focuses on Adenocarcinoma of the Colon and Adenocarcinoma of the Gallbladder and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 6 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Nov 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Philadelphia, United States