Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
Collecte de données
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim (GM-CSF) in patients with advanced solid malignancies. * Determine immune response in patients treated with this regimen. * Determine tumor response in patients treated with this regimen. OUTLINE: Patients are stratified according to prior therapy (biopsy or simple surgery vs radical surgery, chemotherapy, or radiotherapy). Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy. Beginning 24 hours after radiotherapy, patients receive sargramostim (GM-CSF) intratumorally continuously for 1 week and then subcutaneously for 2 weeks. Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment. Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 47 patients (12 for phase I and 35 for phase II) will be accrued for this study.
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.Critères
DISEASE CHARACTERISTICS: * Histologically confirmed solid malignancy * Advanced disease * Radiotherapy is appropriate treatment (i.e., radio-responsive) * No tumors beyond the reach of kilovoltage beam (e.g., \> 15 cm beneath the skin) * At least 1 lesion accessible to needle localization and catheter placement * May be refractory to prior chemotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * 0-4 Life expectancy * At least 2 months Hematopoietic * Hemoglobin ≥ 10 g/dL (RBC transfusion allowed) * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * No excessive leukemic blasts * No bleeding diathesis Hepatic * PT and PTT ≤ 1.5 times upper limit of normal (ULN) * AST or ALT \< 2 times ULN * Alkaline phosphatase \< 2 times ULN Renal * Creatinine \< 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * No contraindication to MRI or CT scan * No medical or psychiatric condition that would preclude giving informed consent * Able to lie flat for 1 hour * No known hypersensitivity to sargramostim (GM-CSF) or any of its components PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed * No concurrent biologic therapy Chemotherapy * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy * Concurrent hormonal therapy allowed Radiotherapy * Prior radiotherapy to planned treatment site allowed * No other concurrent radiotherapy to planned treatment site Surgery * Prior surgery allowed Other * More than 14 days since prior radiosensitizers * No other concurrent investigational therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
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