- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065429
Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
July 9, 2012 updated by: ImmunoGen, Inc.
A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion
This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.
Study Overview
Detailed Description
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers
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Florida
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Ocoee, Florida, United States, 34761
- Cancer Center of Florida
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Massachusetts
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Springfield, Massachusetts, United States, 01107
- Baystate Medical Center
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New York
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Albany, New York, United States, 12208
- New York Oncology Hematology
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Ohio
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Colombus, Ohio, United States, 43221
- The Ohio State University
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Kettering, Ohio, United States, 45409
- Greater Dayton Cancer Center
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South Carolina
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Greenville, South Carolina, United States, 29605
- Cancer Centers of the Carolinas
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Texas
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Houston, Texas, United States, 77030-7095
- MD Anderson Cancer Center
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Tyler, Texas, United States, 75702
- Tyler Cancer Center
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Washington
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Vancouver, Washington, United States, 98684
- Northwest Cancer Specialists
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Histologically or Cytologically proven SCLC, CD 56+ small cell carcinoma of unknown origin, or CD56+ non-pulmonary small cell carcinoma
- Relapsed disease; defined as patients with an initial response (partial or complete) to first-line therapy, then relapse more than 3 months after completion of last chemotherapy.
- Patients must have received no more than 3 prior chemotherapy regimen.
- Patients must have measurable disease defined as: Lesions that can be measured in at least one dimension according to RECIST
- Predicted survival of 3 months or more
- Zubrod performance status 0-2
- Patients must not have received chemotherapy or radiation therapy within 4 weeks of study entry, nor have planned surgery.
- Absolute neutrophils greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 9g/dl and platelets greater than or equal to 100 x 10^9/l.
- Creatinine less than or equal to 1.5 times the upper limit of normal
- AST/ALT less than or equal to 3 times the upper limit of normal without liver metastases; less than or equal to 5 times the upper limit of normal with liver metastases and bilirubin less than or equal to 1.5 times the upper limit of normal.
- Patients must have normal thyroid function (patients receiving thyroxin replacement therapy who are biochemically euthyroid may be enrolled).
- Women of childbearing potential must provide a negative pregnancy test at screening and use adequate contraception in the opinion of the investigator, for the duration of study.
- Patients must be capable of understanding the nature of the trial and must give written witnessed informed consent prior to any screening procedure.
Exclusion:
- Significant residual neurological or cardiac toxicity (grade 3 or 4) following previous chemotherapy
- Patients who are concurrently receiving other anti-neoplastic treatment (chemotherapy, radiotherapy, or immunotherapy including steroid therapy).
- Myocardial infarction within 6 months of study entry, unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled arrythmia, severe aortic stenosis, a history of multiple sclerosis, or other demyelinating disease, Eaton-Lambert Syndrome, history of hemorrhagic stroke, any CNS injury with residual neurologic deficit, ischaemic stroke within the last 6 months, current known herpes zoster (shingles), or cytomegalovirus infection, or a history of recurrent infections with these viruses, chronic alcoholism, serious concomitant infection, or any other concomitant illness considered significant enough to interfere with the study outcome.
- Other investigational agents must not be taken during the study or within 4 weeks of study entry.
- Previous monoclonal antibody therapy
- Patients must not have known central nervous system metastases
- Previous malignancy with < 5 year disease free interval from the last therapeutic intervention, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Patient unwilling or unable to tolerate and comply with the requirements of the study.
- Pregnant or lactating females.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BB-10901, 5mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 10 mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 20 mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 40 mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 60 mg/m2 - Phase I & Phase II
Phase I and Phase II were consecutive and sequential.
Different patients received the 60mg/m2 dose in Phase I and in Phase II.
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 67.5 mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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Experimental: BB-10901, 75 mg/m2 - Phase I
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I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Time Frame: every 6 weeks
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Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.
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every 6 weeks
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Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Time Frame: 6 weeks
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Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks.
CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations.
PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations.
SD: does not qalify for PR or PD based on 2 observations.
PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
July 23, 2003
First Submitted That Met QC Criteria
July 23, 2003
First Posted (Estimate)
July 24, 2003
Study Record Updates
Last Update Posted (Estimate)
July 18, 2012
Last Update Submitted That Met QC Criteria
July 9, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Lorvotuzumab mertansine
Other Study ID Numbers
- C10/IVB/001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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