- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00091052
Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Colorado
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Loveland, Colorado, États-Unis, 80538
- Sirius Medicine, LLC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
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Mesures de résultats secondaires
Mesure des résultats |
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Immune and tumor response as measured by reverse transcriptase polymerase chain reaction (RT-PCR) and CT scan on day 1 and in weeks 2, 3, 4, 12, and 20 or weeks 4, 12, and 20
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Michael D. Weil, MD, Sirius Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000383147
- SIRIUS-1053285
- SIRIUS-01
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