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Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Kidney Cancer, Lung Cancer

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Trial Information

Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with
refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these
patients. III. Assess the overall toxicity and safety of this drug in these patients. IV.
Determine the rate of objective response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2
(KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which more than 33% of the
patients experience a dose-limiting toxicity. Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of 1 of the
following: Renal cell carcinoma Bladder carcinoma Lung carcinoma Refractory disease or
with no anticipated benefit from conventional treatment No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at
least 10 g/dL WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3 Hepatic:
Bilirubin no greater than 3 times upper limit of normal (ULN) AST and ALT no greater than
3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: Normal EKG No prior
myocardial infarction No arteriovenous block greater than I, complete hemiblock,
hypertrophy, or relevant arrhythmia No uncontrolled hypertension (diastolic at least 100
mmHg) or hypotension (systolic no greater than 90 mmHg) No prior episodes of syncope No
prior cardiac disease or significant risk factors for coronary artery disease, unless
there is no evidence of myocardial ischemia on exercise thallium scan or other exam (e.g.,
exercise EKG or dobutamine stress echocardiography) or there is no evidence of
significantly impaired left ventricular function on echocardiographic exam Normal thallium
scan if patient is at least 65 years old Pulmonary: Normal chest x-ray No pulmonary
congestion, pleural effusions, pulmonary fibrosis, or significant emphysema Other: No
concurrent infection No clinical evidence of immunosuppression No known hypersensitivity
to study drug, interleukin-2, Tween-80, or human immunoglobin No other condition that
would preclude study No Addison's disease No Crohn's disease Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 1
month after study Thyroid-sensitizing hormone no greater than 4.7 mU/L

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy
No other concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy
(6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At
least 30 days since prior endocrine therapy No concurrent systemic corticosteroid therapy
Radiotherapy: No prior radiotherapy to at least 25% of bone marrow At least 30 days since
prior radiotherapy At least 3 months since prior radioisotope therapy (e.g., strontium
chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) No concurrent radiotherapy
Surgery: At least 3 weeks since prior major surgery No prior organ transplantation Other:
At least 30 days since prior investigational drug No prior therapy that would preclude
study No other concurrent investigational drugs No concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068612

NCT ID:

NCT00016237

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Kidney Cancer
  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • stage IV non-small cell lung cancer
  • transitional cell carcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Lombardi Cancer CenterWashington, District of Columbia  20007