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Randomized Single Institution Pilot Study of Vaccinia-CEA(6D)-TRICOM and Fowlpox-CEA(6D)-TRICOM With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Cancers

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Ce qui est testé

recombinant fowlpox-CEA(6D)/TRICOM vaccine

+ recombinant vaccinia-CEA(6D)-TRICOM vaccine

+ sargramostim

Médicament
Qui peut participer

Néoplasmes bronchiques+19

+ Carcinome du poumon non à petites cellules

+ Carcinome bronchogénique

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel
Date de début : juin 2004
Voir le détail du protocole

Résumé

Sponsor principalNational Cancer Institute (NCI)
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juin 2004

Date à laquelle le premier participant a commencé l'étude.

OBJECTIVES: I. Determine the recommended dose and schedule of docetaxel when given in combination with recombinant vaccinia-CEA-TRICOM vaccine, recombinant fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF), defined by best immune response with acceptable toxicity, in patients with carcinoembryonic antigen (CEA)-expressing metastatic lung or colorectal cancer. II. Compare the effect of varying doses and schedules of docetaxel on CEA-specific T-cell immune responses by ELISPOT assay in patients treated with these regimens. III. Compare objective antitumor response in patients treated with these regimens. OUTLINE: This is a 2-part, randomized, pilot study. Patients are randomized to 1 of 6 treatment arms: arms I, II, and III in part I (lung cancer and colorectal cancer patients) and arms IV, V, and VI in part II (lung cancer patients only). Patients are stratified according to disease site and HLA-A2 positivity (positive vs negative). At least 6 of 10 patients must be HLA-A2 positive for each of the treatment arms. Vaccinia-CEA-TRICOM vaccine (parts I and II): In all treatment arms, patients receive vaccinia-CEA-TRICOM vaccine intradermally on day 1 and sargramostim (GM-CSF) subcutaneously (SC) into the vaccine site on days 1-4. Fowlpox-CEA-TRICOM vaccine and concurrent chemotherapy: Part I (lung cancer and colorectal cancer patients): ARM 1: Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4. ARM II: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8. ARM III: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8. Part II (lung cancer patients only): ARM IV: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1. ARM V: Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11. ARM VI: Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18. Treatment in all arms repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients who do not have significant disease progression or unacceptable toxicity after 4 courses of treatment may receive additional fowlpox-CEA-TRICOM vaccine and docetaxel according to the treatment arm on which they were enrolled at study entry. Patients are followed every 6 months for 2 years and then annually for 13 years.

Titre officielRandomized Single Institution Pilot Study of Vaccinia-CEA(6D)-TRICOM and Fowlpox-CEA(6D)-TRICOM With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Cancers
NCT00088933
Sponsor principalNational Cancer Institute (NCI)
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

60 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Néoplasmes bronchiquesCarcinome du poumon non à petites cellulesCarcinome bronchogéniqueMaladies du côlonNéoplasmes du côlonMaladies du système digestifNéoplasmes du système digestifMaladies Gastro-intestinalesNéoplasmes Gastro-intestinauxMaladies intestinalesNéoplasmes intestinauxNéoplasmes pulmonairesMaladies pulmonairesNéoplasmes par siteNéoplasmesMaladies RectalesNéoplasmes rectauxMaladies des voies respiratoiresNéoplasmes des Voies RespiratoiresNéoplasmes thoraciquesNéoplasmes ColorectauxCarcinome pulmonaire à petites cellules

Critères

Inclusion Criteria: * Histologically confirmed lung OR colorectal cancer * Incurable metastatic disease * Currently available standard treatment not likely to offer a survival advantage or result in superior palliation * Evaluable disease by radiograph * Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA \>= 10 ng/mL at any point during disease course * No clinically active brain metastases * Must have had first- and second-line treatment OR declined second-line treatment (part I only) * Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only) * ECOG 0-1 * Life expectancy of at least 4 months * Absolute neutrophil count \>= 1,500/mm\^3 * WBC \>= 3,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin normal * Meets 1 of the following criteria: * SGOT and SGPT =\< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal * SGOT and SGPT =\< normal AND alkaline phosphatase =\<4.0 times ULN * Hepatitis B and C negative by clinical history and physical exam * Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 60 mL/min * Proteinuria =\< grade 1 * No known or suspected history of impaired cardiac function as evidenced by baseline echocardiogram * Adequate pulmonary function * No history or clinical evidence of immune deficiency or autoimmunity * HIV negative * No history of or concurrent diagnosis of any of the following: * Altered immunodeficiency * Eczema or other eczematoid skin disorders * Acute, chronic, or exfoliative skin condition (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * No history of allergy or untoward reaction to prior vaccination with vaccinia virus * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No history of allergy to eggs or egg products * No frequent vomiting or severe anorexia * No inflammatory bowel disease * No Crohn's disease * No ulcerative colitis * No active diverticulitis * Neuropathy =\< grade 1 (sensory neuropathy) * No uncontrolled seizure disorder * No encephalitis * No multiple sclerosis * Must be maintaining a reasonable state of nutrition (=\< 10 % weight loss in the past month) * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with individuals with active or a history of eczema or other eczematoid skin disorders * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with those with unresolved acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with any of the following individuals: pregnant or nursing women; children =\< 5 years of age; immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study participation * No other concurrent serious medical illness that would preclude study participation * No concurrent biologic therapy * No other concurrent immunotherapy * At least 6 weeks since prior nitrosoureas or mitomycin * Prior docetaxel allowed (part I only) * No prior docetaxel (part II only) * No other concurrent chemotherapy * No concurrent systemic steroids except for the following: * physiologic doses for systemic steroid replacement therapy * local (topical, nasal, or inhaled) steroid use * no concurrent steroid eye drops * premedication prior to and after docetaxel * No concurrent hormonal therapy * No prior radiotherapy to \> 50 % of all nodal groups * More than 21 days since prior major surgery * No prior splenectomy * Recovered from prior therapy * At least 3-4 weeks since prior cytotoxic therapy

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

6 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.

Groupe II

Expérimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.

Groupe III

Expérimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.

Groupe IV

Expérimental
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.

Groupe 5

Expérimental
Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.

Groupe 6

Expérimental
Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., United StatesOuvrir Lombardi Comprehensive Cancer Center at Georgetown University dans Google Maps
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