Clinical trial NCT00065429: Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
Official title: A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: ImmunoGen, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
timeFrame: every 6 weeks
measure: Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Ocoee
country: United States
facility: Cancer Center of Florida
state: Florida
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Colombus
country: United States
facility: The Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
Study officials:
References: