Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)

NCT00084799 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: LUD2002-015MSKCC 04-012CDR0000365621
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer (SCLC).

Conditions

Lung Cancer

Keywords

recurrent small cell lung cancer (SCLC)

Outcome Measures

Primary Outcomes (1)

• Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging.

  Gamma camera imaging, including planar scans and single-photon emission computed tomography (SPECT) scans, were carried out immediately following completion of infusion and on two subsequent occasions during the next 6 days after the infusions of 111In-hu3S193 on weeks 1 and 4. A pretreatment FDG-positron emission tomography PET/CT scan was performed within 2 weeks of study entry per standard clinical methods for comparison with gamma camera imaging. FDG-PET/ CT scans and 111In planar and SPECT scans were evaluated for extent of disease and antibody targeting, respectively. Lesions on FDG-PET/CT scans were considered positive if uptake of radiotracer was visually greater than surrounding tissue, with a standard uptake value greater than 3.

  28 days

Secondary Outcomes (6)

• Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity

  4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

• Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 Radioactivity

  4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

• Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity

  4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

• Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity

  4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)

• Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193.

  4 weeks (pre-dose, weeks 1, 2, 3, and 4)

Study Arms (2)

hu3S193 10 mg/m2

EXPERIMENTAL

Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 10 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 millicurie (mCi) of indium-111 (111In).

Biological: monoclonal antibody hu3S193

hu3S193 20 mg/m2

EXPERIMENTAL

Patients with small cell lung cancer tumors confirmed to have Lewis Y expression were enrolled to receive 4 weekly injections of hu3S193 at a dose of 20 mg/m2. The dose of hu3S193 given on Weeks 1 and 4 was trace-labeled with 6-8 millicurie (mCi) of indium-111 (111In).

Biological: monoclonal antibody hu3S193

Interventions

monoclonal antibody hu3S193 BIOLOGICAL

hu3S193 10 mg/m2; hu3S193 20 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Small cell lung cancer, pathologically confirmed. Measurable disease, including at least one lesion measuring ≥ 2 cm that has not been previously irradiated.
• Progression of disease after one, two, or three prior chemotherapy regimens. At least 4 weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥ 70% (ECOG 0 or 1).
• The following laboratory results within the last 2 weeks prior to study day 1:
• White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10\^9/L; Serum creatinine ≤ 2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women of childbearing potential with confirmed negative quantitative serum HCG on the day of administration of study agent.
• Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y expression.

You may not qualify if:

• Clinically significant cardiac disease (New York Heart Association Class III/IV).
• Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months. Patients with history of receiving mouse monoclonal antibody. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
• Women who are pregnant or breast-feeding.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

• Krug LM, Milton DT, Jungbluth AA, Chen LC, Quaia E, Pandit-Taskar N, Nagel A, Jones J, Kris MG, Finn R, Smith-Jones P, Scott AM, Old L, Divgi C. Targeting Lewis Y (Le(y)) in small cell lung cancer with a humanized monoclonal antibody, hu3S193: a pilot trial testing two dose levels. J Thorac Oncol. 2007 Oct;2(10):947-52. doi: 10.1097/JTO.0b013e3181560dcc.

  PMID: 17909358 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Hu3S193 monoclonal antibody

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Lee M. Krug, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Chaitanya R. Divgi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: July 26, 2004
• Primary Completion: January 25, 2006
• Study Completion: December 20, 2006
• Last Updated: October 4, 2023
• Results First Posted: February 8, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)