Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule


OBJECTIVES: I. Determine the safety profile and maximum tolerated dose of KRN7000 in
patients with solid tumors. II. Assess the biological and immunological parameters that
would suggest the optimal biologically active dose of KRN7000 in these patients. III.
Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients.
IV. Measure any antitumor activity in these patients treated with this regimen.

OUTLINE: This is a dose escalation study. Patients receive KRN7000 by slow intravenous
injection on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each
receive escalating doses of KRN7000 until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting
toxicity.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor that is
refractory to conventional treatment or for which no curative or standard palliative
treatment exists No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG/WHO 0-2 Life
expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at
least 100,000/mm3 Lymphocyte count at least 600/mm3 Hepatic: Bilirubin less than 1.5 mg/dL
AST and ALT no greater than 2.5 times upper limit of normal No liver cirrhosis Hepatitis B
surface antigen negative Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine
clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV
heart disease Immunologic: No immunodeficiency No autoimmune disease Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception No
active infection No nonmalignant disease incompatible with study No prior alcoholism, drug
addiction, or psychotic disorders unless suitable for adequate follow up No cerebroside
metabolite abnormalities (e.g., Gaucher's disease) HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No
concurrent cytokines Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas, mitomycin, and high dose chemotherapy) Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive
radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent
investigational or antitumor drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-13972

NCT ID:

NCT00003985

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • non-small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • Lung Neoplasms
  • Neoplasms

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