A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies
recombinant interferon alfa
+ cisplatin
+ gemcitabine hydrochloride
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the toxicity and tumor response in patients with metastatic, recurrent, or refractory malignancies treated with cisplatin, gemcitabine, interferon alfa, and long-duration, low temperature whole body hyperthermia (LL-WBH). OUTLINE: This is a dose escalation study of cisplatin. Phase I and II: Patients receive gemcitabine IV over 30 minutes on day 1 and 8. Patients receive cisplatin IV over 6 hours on day 15, followed by subcutaneous interferon alfa on days 16 and 17. Patients undergo long-duration, low temperature whole body hyperthermia over 6 hours plus gemcitabine over 30 minutes on day 17. Courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity. Phase I: Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The MTD of cisplatin is used for phase II study. PROJECTED ACCRUAL: A total of 30 patients 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.30 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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 metastatic, recurrent, or refractory carcinoma Measurable disease by CT, MRI, or physical examination No brain metastases or other CNS disorders PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 90,000/mm^3 Bone marrow cellularity normal on bone marrow biopsy No coagulopathy disorder Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times upper limit of normal PT less than 14 seconds PTT less than 35 seconds No inadequate liver function (no greater than 20% involvement) Renal: Creatinine no greater than 1.8 mg/dL Creatinine clearance at least 45 mL/min BUN no greater than 25 mg/dL Cardiovascular: Adequate cardiac function documented by history, physical exam, or stress exercise test (MUGA or ECHO) with resting blood pressure and heart rate increasing appropriately with exercise LVEF at least 45% No prior myocardial infarction No symptomatic coronary artery disease No angina No significant arrhythmia No uncontrolled hypertension No thromboembolic disease Pulmonary: FEV_1 at least 70% of predicted Arterial PO_2 at least 60 mmHg on room air No massive (greater than 30% involvement) lung disease DLCO greater than 50% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No seizure disorders No significant emotional instability No history of malignant hyperthermia following general anesthesia No other concurrent medical illness that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 6 days since major thoracic or abdominal surgery Other: No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin
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
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
University of Texas Health Science Center at Houston
Houston, United StatesOuvrir University of Texas Health Science Center at Houston dans Google Maps