- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00014092
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
- Determine the safety and tolerability of this regimen in this patient population.
- Determine the changes in quality of life over time in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.
Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94109
- Saint Francis Memorial Hospital
-
Santa Monica, California, États-Unis, 90404
- John Wayne Cancer Institute at Saint John's Health Center
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
-
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 unresectable stage IV melanoma
- Measurable metastatic disease
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
Renal:
- BUN no greater than 1.5 times ULN
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No significant cardiovascular disease
Other:
- No non-malignant systemic disease
- No acute infection requiring IV antibiotics
- No alcohol or substance abuse
- No other condition, disease, or history of other illness that would preclude study participation
- No hypersensitivity, allergic reactions, or intolerance to study drugs
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No prior interleukin-2
- No other concurrent immunotherapy
- No concurrent investigational vaccines or immunomodulatory agents
- No other concurrent growth factors
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior temozolomide
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent steroids (including corticosteroids)
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior major surgery
Other:
- At least 30 days since prior immune-based therapy
- No concurrent participation in other clinical trials with investigational drugs
- No other concurrent anticancer drugs
- No concurrent immunosuppressive therapy
- No concurrent levamisole or cimetidine
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Lynn E. Spitler, MD, Northern California Melanoma Center at St. Francis Memorial Hospital
Publications et liens utiles
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
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Mélanome
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Agents anti-VIH
- Agents antirétroviraux
- Agents antinéoplasiques
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Interférons
- Interféron-alpha
- Aldesleukine
- Témozolomide
- Sargramostim
Autres numéros d'identification d'étude
- CDR0000067958
- SFMH-BB-IND-5301
- NCI-V00-1591
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Mélanome (Peau)
-
Utah State UniversityActif, ne recrute pasTrouble d'excoriation (skin-picking)États-Unis
-
Karolinska InstitutetRegion StockholmComplétéTrichotillomanie | Trouble d'excoriation (skin-picking)Suède
Essais cliniques sur aldesleukine
-
Carman GiacomantonioNova Scotia Health AuthorityRetiréLa réponse au traitement intralésionnel par l'IL-2 et/ou le BCG pour le mélanome cutané métastatiqueMélanome métastatique cutané
-
Groupe Francophone des MyelodysplasiesEpiCept CorporationRetiréSyndromes myélodysplasiquesFrance