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A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer


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

Thank you

Trial Information

A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer


OBJECTIVES:

Primary

- Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal
antibody Hu3S193 in patients with progressive small cell lung cancer.

Secondary

- Determine the immunogenicity of this drug in these patients.

- Determine tumor response in patients treated with this drug.

- Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive monoclonal antibody Hu3S193 (MOAB Hu3S193) IV over 30 minutes on day 1 of
weeks 1-4. Patients also receive indium In III MOAB Hu3S193 IV over 30 minutes on day 1 of
weeks 1 and 4 and then undergo gamma camera imaging. Treatment continues in the absence of
disease progression or unacceptable toxicity.

Patients are followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12
months thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed small cell lung cancer

- Progressive disease after 1-3 prior chemotherapy regimens

- Measurable disease

- At least 1 measurable lesion ≥ 2 cm that is not in a previously irradiated field

- Positive immunohistochemical staining for Lewis Y

- No uncontrolled brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100% OR

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,500/mm^3

- Platelet count ≥ 150,000/mm^3

Hepatic

- Bilirubin ≤ 2.0 mg/dL

- INR ≤ 1.3

Renal

- Creatinine ≤ 2.0 mg/dL

Cardiovascular

- No clinically significant cardiac disease

- No New York Heart Association class III or IV cardiac disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Stool guaiac test negative

- No gastrointestinal bleed within the past 6 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior mouse monoclonal antibody

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- More than 4 weeks since prior participation in any other clinical trial involving
another investigational agent

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000365621

NCT ID:

NCT00084799

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021