Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer
recombinant flt3 ligand
Maladies du côlon+13
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection. OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and metastasis resection. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter. PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year.
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.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.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
Critères
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer that is resectable (e.g., lung metastases) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3 Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use effective contraception No history of autoimmune disease such as but not limited to: Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No medical or psychological impediment to study compliance No concurrent or prior second malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within the last 5 years No active or chronic infection including: Urinary tract infection HIV Viral hepatitis PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other: No immunosuppressives such as: Azathioprine Cyclosporine A
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
Duke Comprehensive Cancer Center
Durham, United StatesOuvrir Duke Comprehensive Cancer Center dans Google Maps