- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00014248
Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
A Phase I Study And Pharmacokinetics Of Adenosine 5'- Triphosphate (ATP) When Administered By Intravenous Infusion On A Multiple Weekly Dose Schedule To Patients With Advanced Malignancies (Solid Tumors)
RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in patients with advanced solid tumors.
PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling loss of weight and loss of muscle mass in patients who have advanced solid tumors.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Determine the individualized maximum tolerated dose of adenosine triphosphate in patients with advanced solid tumors.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the effect of this regimen on quality of life of these patients.
- Determine the influence of this regimen on cancer cachexia in terms of weight change, percentage of body fat, voluntary muscle strength, and plasma markers in these patients.
- Determine the effect of this regimen on tumor burden in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive adenosine triphosphate (ATP) IV over 8 hours on day 0. Treatment repeats weekly for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Each patient receives escalating doses of ATP until the individual maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which the patient experiences at least grade 3 (at least grade 2 cardiac ischemia or arrhythmia) toxicity.
Weight is measured at baseline and at weeks 1-8, 10, and 13. Percentage of body fat and skeletal muscle strength is measured at baseline and at weeks 2, 4, 8, 10, and 13.
Quality of life is assessed at baseline and at weeks 2, 4, 8, 10, and 13.
Patients are followed at weeks 10 and 13.
PROJECTED ACCRUAL: A maximum of 13-24 patients will be accrued for this study.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756-0002
- Norris Cotton Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced solid tumor that is not curable by conventional therapy
- Brain metastases allowed if adequately controlled with radiotherapy
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT and SGPT no greater than 3 times normal
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
- BUN no greater than 25 mg/dL
Cardiovascular:
- Adequate cardiovascular function
- No congestive heart failure (New York Heart Association class III or IV heart disease)
- No angina pectoris AND/OR
- No significant arrhythmia
- No myocardial infarction within the past 6 months
- No clinically significant ischemic cardiac disease currently under treatment
- No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block)
Pulmonary:
- Adequate pulmonary function
- No clinical evidence of acute chronic obstructive pulmonary disease
- FEV1 at least 50% predicted
- Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air
- No asthma OR
- No evidence of more than 20% reversibility in FEV1 with albuterol therapy
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of severe adverse reaction to adenosine
- No uncontrolled medical illness
- No average daily pain scores of at least 5 on a simple Visual Analogue Self pain assessment (0-10) scale
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- At least 30 days since prior investigational therapy
- At least 14 days since prior long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- No concurrent maintenance anti-anginal drug therapy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Lionel D. Lewis, MD, Norris Cotton Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Stoffwechselerkrankungen
- Ernährungsstörungen
- Körpergewicht
- Änderungen des Körpergewichts
- Abmagerung
- Gewichtsverlust
- Wasting-Syndrom
- Kachexie
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Anti-Arrhythmie-Mittel
- Vasodilatator-Wirkstoffe
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Purinerge Wirkstoffe
- Purinerge P1-Rezeptor-Agonisten
- Purinerge Agonisten
- Adenosin
Andere Studien-ID-Nummern
- CDR0000068522
- DMS-0005
- ATP-DMS-0005
- NCI-G01-1923
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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