Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
Primary
- Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
Secondary
-
Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
-
Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
-
Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
OUTLINE: This is an open-label, pilot study.
Patients received monoclonal antibody hu3S193 (mAb hu3S193) intravenously (IV) over 30 minutes on day 1 of weeks 1-4. Patients also received indium-111 (111In) radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging. Treatment continued in the absence of disease progression or unacceptable toxicity.
Patients were followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: hu3S193 10 mg/m2 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
|
| Experimental: hu3S193 20 mg/m2 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
|
Outcome Measures
Primary Outcome Measures
- 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. [28 days]
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.
Secondary Outcome Measures
- Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity [4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)]
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
- 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)]
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
- Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity [4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)]
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
- Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity [4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)]
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
- 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)]
Blood samples to measure human anti-human antibody (HAHA) assessments were obtained at baseline and each week before hu3S193 dosing. Measurement of immune responses to hu3S193 in patient blood samples was analyzed using a BIACORE (Piscataway, NJ) instrument using surface plasmon resonance (SPR).
- Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST [up to 28 days]
Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Therasse P et al. 2000).
Eligibility Criteria
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Ludwig Institute for Cancer Research
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Lee M. Krug, MD, Memorial Sloan Kettering Cancer Center
- Principal Investigator: Chaitanya R. Divgi, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
- LUD2002-015
- MSKCC 04-012
- CDR0000365621
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Period Title: Overall Study | ||
| STARTED | 5 | 5 |
| COMPLETED | 4 | 5 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 | Total |
|---|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). | Total of all reporting groups |
| Overall Participants | 5 | 5 | 10 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
60%
|
4
80%
|
7
70%
|
| >=65 years |
2
40%
|
1
20%
|
3
30%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
60%
|
2
40%
|
5
50%
|
| Male |
2
40%
|
3
60%
|
5
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
5
100%
|
5
100%
|
10
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
20%
|
1
10%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
20%
|
0
0%
|
1
10%
|
| White |
4
80%
|
4
80%
|
8
80%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
5
100%
|
5
100%
|
10
100%
|
Outcome Measures
| Title | 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. |
|---|---|
| Description | 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. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| Count of Participants [Participants] |
5
100%
|
5
100%
|
| Title | Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity |
|---|---|
| Description | Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters. |
| Time Frame | 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| T½α |
13.28
(11.02)
|
7.45
(7.06)
|
| T½β |
126.22
(35.35)
|
129.60
(51.93)
|
| Title | Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 Radioactivity |
|---|---|
| Description | Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters. |
| Time Frame | 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| Mean (Standard Deviation) [mL] |
3040.78
(565.38)
|
3468.07
(686.79)
|
| Title | Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity |
|---|---|
| Description | Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters. |
| Time Frame | 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| Mean (Standard Deviation) [mL/hour] |
28.83
(15.32)
|
30.81
(10.18)
|
| Title | Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity |
|---|---|
| Description | Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters. |
| Time Frame | 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| Mean (Standard Deviation) [hours*g/mL] |
859.97
(347.19)
|
1327.00
(465.47)
|
| Title | Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193. |
|---|---|
| Description | Blood samples to measure human anti-human antibody (HAHA) assessments were obtained at baseline and each week before hu3S193 dosing. Measurement of immune responses to hu3S193 in patient blood samples was analyzed using a BIACORE (Piscataway, NJ) instrument using surface plasmon resonance (SPR). |
| Time Frame | 4 weeks (pre-dose, weeks 1, 2, 3, and 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| Number of Patients with HAHA |
0
0%
|
0
0%
|
| Number of Patients without HAHA |
5
100%
|
5
100%
|
| Title | Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST |
|---|---|
| Description | Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Therasse P et al. 2000). |
| Time Frame | up to 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who received at least one dose of hu3S193. |
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 |
|---|---|---|
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). |
| Measure Participants | 5 | 5 |
| CR |
0
0%
|
0
0%
|
| PR |
0
0%
|
0
0%
|
| SD |
0
0%
|
0
0%
|
| PD |
5
100%
|
5
100%
|
Adverse Events
| Time Frame | up to 8 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF). Adverse events which occurred prior to the first administration of study drug were documented on the Pre-existing symptoms CRF page, thereafter, they were documented on the Adverse Event CRF page. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published April 16, 2003). | |||
| Arm/Group Title | hu3S193 10 mg/m2 | hu3S193 20 mg/m2 | ||
| Arm/Group Description | 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 mCi of indium-111 (111In). | 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 mCi of indium-111 (111In). | ||
All Cause Mortality |
||||
| hu3S193 10 mg/m2 | hu3S193 20 mg/m2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/5 (0%) | ||
Serious Adverse Events |
||||
| hu3S193 10 mg/m2 | hu3S193 20 mg/m2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/5 (20%) | 0/5 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 1/5 (20%) | 0/5 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| hu3S193 10 mg/m2 | hu3S193 20 mg/m2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/5 (100%) | 5/5 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphopenia | 1/5 (20%) | 2/5 (40%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/5 (20%) | 2/5 (40%) | ||
| Nausea | 2/5 (40%) | 1/5 (20%) | ||
| Constipation | 1/5 (20%) | 0/5 (0%) | ||
| Dry mouth | 1/5 (20%) | 0/5 (0%) | ||
| Vomiting | 1/5 (20%) | 3/5 (60%) | ||
| General disorders | ||||
| Chest pain | 1/5 (20%) | 0/5 (0%) | ||
| Fatigue | 2/5 (40%) | 0/5 (0%) | ||
| Hepatobiliary disorders | ||||
| Hyperbillirubinemia | 1/5 (20%) | 2/5 (40%) | ||
| Injury, poisoning and procedural complications | ||||
| Radiation skin injury | 1/5 (20%) | 0/5 (0%) | ||
| Investigations | ||||
| Blood creatinine | 3/5 (60%) | 2/5 (40%) | ||
| Hemoglobin | 3/5 (60%) | 5/5 (100%) | ||
| International normalised ratio | 1/5 (20%) | 0/5 (0%) | ||
| Activated partial thromboplastin time | 1/5 (20%) | 0/5 (0%) | ||
| Alanine aminotransferase | 2/5 (40%) | 2/5 (40%) | ||
| Aspartate aminotransferase | 2/5 (40%) | 2/5 (40%) | ||
| Blood alkaline phosphatase | 1/5 (20%) | 2/5 (40%) | ||
| Blood creatine phosphokinase | 1/5 (20%) | 0/5 (0%) | ||
| Platelet count | 1/5 (20%) | 2/5 (40%) | ||
| White blood cell count | 0/5 (0%) | 2/5 (40%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperkalaemia | 2/5 (40%) | 1/5 (20%) | ||
| Hypoalbuminaemia | 5/5 (100%) | 4/5 (80%) | ||
| Hypokalaemia | 1/5 (20%) | 0/5 (0%) | ||
| Hyponatraemia | 2/5 (40%) | 1/5 (20%) | ||
| Hyperglycaemia | 5/5 (100%) | 5/5 (100%) | ||
| Hypernatraemia | 1/5 (20%) | 0/5 (0%) | ||
| Decreased appetite | 1/5 (20%) | 1/5 (20%) | ||
| Nervous system disorders | ||||
| Headache | 0/5 (0%) | 1/5 (20%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2/5 (40%) | 2/5 (40%) | ||
| Dyspnoea | 2/5 (40%) | 0/5 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dry skin | 0/5 (0%) | 1/5 (20%) | ||
| Skin exfoliation | 1/5 (20%) | 0/5 (0%) | ||
| Urticaria | 0/5 (0%) | 1/5 (20%) | ||
| Vascular disorders | ||||
| Hypertension | 0/5 (0%) | 1/5 (20%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mary Macri, Senior Director, Clinical Trials Management |
|---|---|
| Organization | Ludwig Institute for Cancer Research |
| Phone | 12124501546 |
| mmacri@lcr.org |
- LUD2002-015
- MSKCC 04-012
- CDR0000365621