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| Sponsor: | Fox Chase Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028496 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Gallbladder Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Ovarian Cancer Pancreatic Cancer Testicular Germ Cell Tumor |
Biological: recombinant fowlpox GM-CSF vaccine adjuvant Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity.
The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days.
The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF). rF-GM-CSF is administered in the same manner as GM-CSF.
Patients are followed every month for 4 months.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1.2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8 weeks
HLA phenotyping required
No clinically symptomatic brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Neurologic:
Immunologic:
No autoimmune diseases, including the following:
Other:
No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Study Chair: | Margaret von Mehren, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000069093, FCCC-01016, NCI-1133 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028496 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III colon cancer stage IV colon cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage IIIB breast cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer advanced adult primary liver cancer recurrent adult primary liver cancer unresectable gallbladder cancer recurrent gallbladder cancer thyroid gland medullary carcinoma stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer Paget disease of the breast with intraductal carcinoma Paget disease of the breast with invasive ductal carcinoma adult primary hepatocellular carcinoma intestinal adenocarcinoma of the stomach adenocarcinoma of the colon diffuse adenocarcinoma of the stomach |
|
Gallbladder Diseases Liver Diseases Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Ovarian Diseases Rectal Diseases Genital Diseases, Female Liver Neoplasms Neoplasms by Site Stomach Diseases Biliary Tract Diseases Neoplasms, Germ Cell and Embryonal |
Stomach Neoplasms Breast Diseases Endocrine Gland Neoplasms Neoplasms by Histologic Type Biliary Tract Neoplasms Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Adnexal Diseases Neoplasms |