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A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia


N/A
2 Years
17 Years
Not Enrolling
Both
Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Neutropenia, Sarcoma

Thank you

Trial Information

A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia


OBJECTIVES:

- Determine the pharmacokinetics and serum levels of caspofungin acetate in
immunocompromised children with new-onset fever and neutropenia.

- Determine the safety and tolerability of this drug in this patient population.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
age (2 to 11 vs 12 to 17).

Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the
absence of the need to start standard empirical antifungal therapy, a breakthrough fungal
infection, any deterioration of patient condition, or unacceptable toxicity.

Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels.
Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences
dose-limiting toxicity at dose level 1.

Patients are followed at 14 days.

PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum)
will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Immunocompromised with one or more of the following conditions:

- Leukemia, lymphoma, or other cancer

- Underwent bone marrow or peripheral blood stem cell transplantation

- Aplastic anemia

- Planned chemotherapy likely to incur more than 10 days of neutropenia

- Absolute neutrophil count no greater than 500/mm^3 AND at least 1 recorded fever over
38.0 ° C within 24 hours of study

- No proven invasive fungal infection at time of study entry

- Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or
candidal vaginitis) treatable with topical antifungals allowed

PATIENT CHARACTERISTICS:

Age:

- 2 to 17

Performance status:

- Not specified

Life expectancy:

- At least 5 days

Hematopoietic:

- See Disease Characteristics

- Hemodynamically stable with no hemodynamic compromise

Hepatic:

- AST or ALT no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases
or other suspected bony processes)

- INR no greater than 1.6 (4.0 if receiving anticoagulants)

- No acute hepatitis or cirrhosis

Renal:

- Not specified

Other:

- Functioning central venous catheter in place

- No other condition or concurrent illness that would preclude study

- No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception other than or in addition to oral
contraceptives

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No prior enrollment into this study

- No more than 48 hours since prior parenteral systemic antibacterial therapy for fever
and neutropenia

- At least 14 days since prior investigational antibiotic or antifungal drugs

- Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a
superficial fungal infection allowed

- No other concurrent investigational drugs, including antibiotics or antifungals

- No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or
other antifungal treatments (except fluconazole)

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Thomas J. Walsh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068564

NCT ID:

NCT00020527

Start Date:

March 2001

Completion Date:

June 2003

Related Keywords:

  • Fever, Sweats, and Hot Flashes
  • Infection
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Neutropenia
  • Sarcoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood rhabdomyosarcoma
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • recurrent Wilms tumor and other childhood kidney tumors
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • fever, sweats, and hot flashes
  • childhood acute promyelocytic leukemia (M3)
  • recurrent/refractory childhood Hodgkin lymphoma
  • neutropenia
  • infection
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • previously treated childhood rhabdomyosarcoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Fever
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Neutropenia
  • Hot Flashes
  • Sarcoma

Name

Location
Lombardi Cancer Center Washington, District of Columbia  20007
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Children's National Medical Center Washington, District of Columbia  20010-2970
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182