Protocol Number: 04-C-0246

Title:

An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination with Sargramostim in Adults with Metastatic Carcinoma

Number:

04-C-0246

Summary:

Background:

-Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1).

-The PANVAC-V priming vaccine and PANVAC-F boosting vaccine contain human genes that cause production of CEA and MUC-1, which can be used as a target for the immune system to attack the cancer. The vaccines also contain genes that cause production of other proteins that enhance immune activity.

-Sargramostim is a protein that boosts the immune system.

Objectives:

-To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with advanced cancer.

-To document the immune response to the vaccines and any anti-tumor responses that may occur.

Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA or MUC-1 protein

Design:

-This trial has four arms: the first arm includes 10 patients with advanced colorectal cancer; the second arm includes 10 to 15 patients with any advanced non-colorectal cancer that produces either EA or MCU-1; the third arm includes about 12 patients with advanced breast cancer; the fourth arm includes about 12 patients with advanced ovarian cancer.

-All patients receive PANVAC-V on study day 1, followed by PANVAC-F on days 15, 29 and 43. The vaccines are given by injection under the skin. Sargramostim is injected at the vaccination site on the day of each vaccination and for the next 3 days following vaccination.

-Patients whose disease has not worsened after the last boosting vaccination may receive up to 12 additional monthly boosting vaccinations. Following the 12 vaccinations, patients may receive vaccine every 3 months. Patients whose scans show that their disease has progressed, but who are otherwise clinically stable may revert back to monthly injections.

-Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day 71 of the study to measure the immune response to the treatment. Blood is collected through a needle placed in one arm and directed through a cell separator machine where the lymphocytes are extracted. The rest of the blood components are returned to the patient through the same needle.

-Patients are monitored with frequent blood tests and periodic imaging tests (scans) to monitor for safety and the response to treatment.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

CEA

Vaccine

Immunotherapy

GM-CSF

MUC-1

Recruitment Keyword(s):

Cancer

Adenocarcinoma

Metastatic Adenocarcinoma

Condition(s):

Adenocarcinoma

Investigational Drug(s):

PANVAC-V [Recombinant-Vaccinia-CEA (D609)/MUC-1(L93)/TRICOM]

PANVAC-F [Recombinant-Fowlpox-CEA (D609)/MUC-1(L93)/TRICOM]

Investigational Device(s):

None

Interventions:

Drug: PANVAC-V [Recombinant-Vaccinia-CEA (D609)/MUC-1(L93)/TRICOM]

Drug: PANVAC-F [Recombinant-Fowlpox-CEA (D609)/MUC-1(L93)/TRICOM]

Drug: Leukine (Sargramostim)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Scheithauer W, Kornek GV, Brugger S, Ullrich-Pur H, Valencak J, Raderer M, Fiebiger W, Kovats E, Lang F, Depisch D. Randomized phase II study of irinotecan plus mitomycin C vs. oxaliplatin plus mitomycin C in patients with advanced fluoropyrimidine/leucovorin-pretreated colorectal cancer. Cancer Invest. 2002;20(1):60-8.

Falcone A, Masi G, Allegrini G, Danesi R, Pfanner E, Brunetti IM, Di Paolo A, Cupini S, Del Tacca M, Conte P. Biweekly chemotherapy with oxaliplatin, irinotecan, infusional Fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol. 2002 Oct 1;20(19):4006-14.

Carlomagno C, Lauria R, De Laurentiis M, Arpino G, Massarelli E, Ferrara C, Milano A, Vernaglia Lombardi A, Costanzo R, Catalano G, Bianco AR, De Placido S. Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU. A phase 2 study. Oncology. 2002;63(3):219-25.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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