TerminatedPhase 2

Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems

Stopped: competing study at site

United States13 participantsStarted 2003-08

Plain-language summary

RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems. PURPOSE: This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of probable or definite invasive fungal infection with 1 of the following organisms: * Aspergillus species * Fusarium species * Scedosporium species (Pseudallescheria boydii) * Other dematiaceous molds * The following diagnosis are not allowed: * Zygomycetes (Mucor or Rhizopus species) * Chronic aspergillosis * Aspergilloma * Allergic bronchopulmonary aspergillosis * Must be immunocompromised PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * At least 72 hours Hematopoietic * Not specified Hepatic * AST \< 5 times upper limit of normal (ULN) * Bilirubin \< 5 times ULN * Alkaline phosphatase \< 5 times ULN * No Child-Pugh class C cirrhosis Renal * Creatinine clearance ≥ 50 mL/min Pulmonary * No mechanical ventilation Other * Not pregnant or nursing * Fertile patients must use effective contraception * No hypersensitivity to azoles, caspofungin acetate, or their components * No history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 14 days since prior therapeutic antifungal therapy of ≥ 1 week duration * More than 14 days since prior and no concurrent administration of any of the following medications: * Terfenadine …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.

Timeframe: 12 weeks after starting treatment

Trial details

NCT IDNCT00238355

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2011-11-07

View on ClinicalTrials.gov More Infection trials