- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00278122
Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective clinical response rate (complete response [CR] and partial response [PR]), in patients with advanced unresectable melanoma.
Secondary
- Evaluate the duration of response, time to progression, and overall survival of patients treated with this regimen.
- Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4, and IL-10) in these patients.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV over 3 hours on day 1 and sargramostim (GM-CSF) subcutaneously on days 4-17. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR for up to 12 courses.
After study treatment, patients are followed every 3-6 months for at least 3 years.
PROJECTED ACCRUAL: A total of 42 patients will accrued for this study.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Cancer Center
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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 or cytologically confirmed unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site
Unresectable stage III disease, defined as meeting 1 of the following criteria:
- Regional metastasis that, in the judgement of the treating physician, cannot be surgically resected with clear margins
- Regional metastasis that can be surgically resected with clear margins only by extensive surgery that is inadvisable or unacceptable to the treating physician and/or patient
- Staging of cutaneous and mucosal melanoma based on the revised American Joint Committee on Cancer (AJCC) staging system
- Must have measurable disease as defined by Response Evaluation Criteria in Small Tumors (RECIST) criteria
- No ocular melanoma
Patients with brain metastases may be eligible if all of the following are true:
- Total number of brain metastases ever is ≤ 3
Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery
- Stereotactic radiosurgery, such as gamma knife, can be used up to 1 week before study entry
- No evident growth of any brain metastasis since treatment
- No brain metastasis that is > 2 cm in diameter at study entry
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin normal
- Creatinine ≤ 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No previous or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy
No autoimmune disorder with visceral involvement
The following conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring steroidal anti-inflammatory drugs
- HIV negative
- Hepatitis C negative
- No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy
PRIOR CONCURRENT THERAPY:
- No more than 1 previous chemotherapy regimen for metastatic melanoma
- No previous paclitaxel
- No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excluding gamma knife therapy for brain metastases) within the past 4 weeks
- No surgical resection of metastatic lesions within the past 4 weeks
- No other investigational medication within the past 4 weeks or during study
- No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and during study treatment
- No other concurrent chemotherapy, interferon, other growth factors, interleukin, illegal drugs, radiotherapy, surgery, or steroid therapy
- No concurrent oral or injectable hydrocortisone (at doses > 15 mg per day) or its equivalent
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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Clinical response by CT scans every 6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
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Survie
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Duration of response by CT scans every 6 weeks
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Time to progression by CT scans every 6 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: William W. Grosh, MD, University of Virginia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
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
- 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 antinéoplasiques
- Facteurs immunologiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Paclitaxel
- Sargramostim
Autres numéros d'identification d'étude
- 11782 (DAIDS ES Registry Number)
- UVACC-MEL-46
- UVACC-HIT-028.8
- UVACC-PRC-350-04
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 .
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