Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis - Full Text View

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00404092

Purpose

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.

Condition	Intervention	Phase
Invasive Aspergillosis	Drug: caspofungin	Phase II

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis

Further study details as provided by University of Cologne:

Primary Outcome Measures:

safety and tolerability of caspofungin in four escalating dosages defined as number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events [ Time Frame: at end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

efficacy of caspofungin in four escalating dosages [ Time Frame: at 12 week follow-up ] [ Designated as safety issue: No ]
pharmacokinetics of caspofungin in four escalating dosages [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1st cohort: Experimental 70mg 1x/day	Drug: caspofungin i.v.
2nd cohort: Experimental 100mg 1x/day	Drug: caspofungin i.v.
3rd cohort: Experimental 150mg 1x/day	Drug: caspofungin i.v.
4th cohort: Experimental 200mg 1x/day	Drug: caspofungin i.v.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404092

Contacts

Contact: Oliver A. Cornely, MD	+49-221-478 6494	oliver.cornely@uni-koeln.de
Contact: Dorothee Arenz	+49-221-478 88790	dorothee.arenz@uni-koeln.de

Locations

Belgium
University Hospital Gasthuisberg	Not yet recruiting
Leuven, Belgium, 3000
Principal Investigator: Johan Maertens, MD
Germany
Klinikum der Universität zu Köln	Recruiting
Köln, Germany, 50924
Contact: Dorothee Arenz +49-221-478 6494 dorothee.arenz@uni-koeln.de
Principal Investigator: Oliver A. Cornely, MD
Universitätsklinikum Münster	Recruiting
Münster, Germany, 48149
Principal Investigator: Andreas H. Groll, MD
Charité - Campus Benjamin Franklin	Recruiting
Berlin, Germany, 12200
Principal Investigator: Stefan Schwartz, MD

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Oliver A. Cornely, MD

Klinikum der Universität zu Köln

More Information

Responsible Party:	University Hospital of Cologne ( Prof. Dr. med. Oliver Cornely )
Study ID Numbers:	Uni-Koeln-687, EudraCT- No.: 2006-001936-30
Study First Received:	November 24, 2006
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00404092
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

aspergillosis
caspofungin
maximum tolerated dose

Study placed in the following topic categories:

Mycoses
Clotrimazole
Miconazole

Caspofungin
Tioconazole
Aspergillosis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009