Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis |
- 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 ] [ Designated as safety issue: Yes ]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.
- Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. [ Time Frame: End of caspofungin treatment ] [ Designated as safety issue: No ]The primary variable of antifungal efficacy is therapeutic success, defined as the complete or partial response of initial proven or probable aspergillosis at the end of caspofungin treatment. Other efficacy variables include assessments of relapse of IA at four and twelve weeks after the end of caspofungin study therapy (in those patients with therapeutic success at the end of therapy), the absence of study drug discontinuations due to toxicity or lack of efficacy, and survival to end of treatment.
| Enrollment: | 46 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1st cohort
70mg 1x/day
|
Drug: caspofungin
i.v.
|
|
Experimental: 2nd cohort
100mg 1x/day
|
Drug: caspofungin
i.v.
|
|
Experimental: 3rd cohort
150mg 1x/day
|
Drug: caspofungin
i.v.
|
|
Experimental: 4th cohort
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 |
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| Belgium | |
| University Hospital Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Germany | |
| Charité - Campus Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| Klinikum der Universität zu Köln | |
| Köln, Germany, 50924 | |
| Universitätsklinikum Münster | |
| Münster, Germany, 48149 | |
| Principal Investigator: | Oliver A. Cornely, MD | Klinikum der Universität zu Köln |
More Information
No publications provided by University of Cologne
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oliver Cornely, MD, Prof. Dr. Oliver Cornely, University of Cologne |
| ClinicalTrials.gov Identifier: | NCT00404092 History of Changes |
| Other Study ID Numbers: | Uni-Koeln-687, EudraCT- No.: 2006-001936-30 |
| Study First Received: | November 24, 2006 |
| Results First Received: | December 12, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Cologne:
|
aspergillosis caspofungin maximum tolerated dose |
Additional relevant MeSH terms:
|
Aspergillosis Mycoses Caspofungin Echinocandins |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013