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Completed

NCT Number: NCT00404092

Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis.

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Key information

Conditions

Invasive Aspergillosis Aspergillosis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Gasthuisberg, Leuven, Belgium

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About this study

Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, favorable pharmacokinetic properties, and excellent tolerability according to the current data, caspofungin is a highly promising candidate for improving the results of treatment of invasive fungal infections.

Preclinical and clinical data indicate a dose dependent antifungal efficacy of caspofungin as well as of other echinocandins such as micafungin and anidulafungin. Thus it appears reasonable to investigate the impact of higher doses of caspofungin to improve the results already achieved with this component so far.

The maximum tolerated dose (MTD) of caspofungin and the distribution of the drug in patients following administration of doses of 70 mg or more are not yet known. We therefore investigate the safety, tolerability and pharmacokinetics of caspofungin in rising doses in a dose escalation study in adult patients with proven or probable invasive aspergillosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
  • Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

Exclusion criteria

  • Concomitant other systemic antifungal agents are not permitted on study.
  • Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study
  • Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days of study enrollment
  • Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.

Treatment and study plan

Caspofungin

Drug

i.v.

Other names: cancidas

Primary outcomes

  1. Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis

    Time frame: End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)

    Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.

Secondary outcomes

  1. Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.

    Time frame: End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up

    Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU.

    Definitions:

    CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.

    PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities.

    Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.

    Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death.

    Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 27, 2006
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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