Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Caspofungin; Echinocandins

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of proven or probable invasive aspergillosis (IA)

• Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry

• Meets any of the following criteria:

• Diagnosis of a hematologic malignancy

• Underwent autologous or allogeneic hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 20-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST and ALT ≤ 5 times upper limit of normal (ULN)

• Bilirubin ≤ 5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• No severe hepatic insufficiency

• Child-Pugh score ≤ 9

Renal

• No severe renal failure requiring hemodialysis or peritoneal dialysis

• Creatinine < 3.4 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception

• No known HIV positivity

• No history of allergy or adverse reaction to echinocandin drugs

• No known bacterial infection that is not adequately treated

• No psychological, familial, social, or geographical condition that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours

• Prior prophylactic oral antifungals allowed

• Prior prophylactic IV fluconazole allowed

• More than 14 days since prior and no concurrent investigational agents

• No prior participation in this study

• No prior echinocandins

• No other concurrent antifungal therapy