Small Cell Lung CancerPhase 1/2NCT00065429
Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
A Phase 1/2 study testing BB-10901 in people with Small Cell Lung Cancer, run by ImmunoGen, Inc. at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- BB-10901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2003to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New York Oncology Hematology
Albany, New York, 12208
The Ohio State University
Colombus, Ohio, 43221
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
MD Anderson Cancer Center
Houston, Texas, 77030-7095
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Center of Florida
Ocoee, Florida, 34761
Baystate Medical Center
Springfield, Massachusetts, 01107
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists
Vancouver, Washington, 98684
About this study
Official title: 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.
Read the 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).
- Conditions
- Small Cell Lung Cancer
- Being tested
- BB-10901
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-10901Drug
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
| Study group | Role | What they receive |
|---|---|---|
| BB-10901, 5mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
| BB-10901, 10 mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
| BB-10901, 20 mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
| BB-10901, 40 mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
| BB-10901, 60 mg/m2 - Phase I & Phase II | Experimental | Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II. Receives: Drug: BB-10901 |
| BB-10901, 67.5 mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
| BB-10901, 75 mg/m2 - Phase I | Experimental | Not described Receives: Drug: BB-10901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
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.
Measured: every 6 weeks
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2003 (estimated)
- Study startApr 2003
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065429
- Sponsor's protocol ID
- C10/IVB/001
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2003
- Last updated
- 18 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion
- ClinicalTrials.gov ID
- NCT00065429
- Acronym / sponsor ID
- C10/IVB/001
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ImmunoGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jul 2003 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BB-10901, 5mg/m2 - Phase I | Experimental | Drug: BB-10901 |
| BB-10901, 10 mg/m2 - Phase I | Experimental | Drug: BB-10901 |
| BB-10901, 20 mg/m2 - Phase I | Experimental | Drug: BB-10901 |
| BB-10901, 40 mg/m2 - Phase I | Experimental | Drug: BB-10901 |
| BB-10901, 60 mg/m2 - Phase I & Phase II | Experimental | Drug: BB-10901Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II. |
| BB-10901, 67.5 mg/m2 - Phase I | Experimental | Drug: BB-10901 |
| BB-10901, 75 mg/m2 - Phase I | Experimental | Drug: BB-10901 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-10901I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease. | Drug | BB-10901, 10 mg/m2 - Phase I, BB-10901, 20 mg/m2 - Phase I, BB-10901, 40 mg/m2 - Phase I, BB-10901, 5mg/m2 - Phase I, BB-10901, 60 mg/m2 - Phase I & Phase II, BB-10901, 67.5 mg/m2 - Phase I, BB-10901, 75 mg/m2 - Phase I |
Primary outcome
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Time frame: every 6 weeks
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.
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Time frame: 6 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BB-10901 in people with Small Cell Lung Cancer, run by ImmunoGen, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I) (time frame: every 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.