Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.
• Treatments: Lorvotuzumab mertansine

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.