BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS During Dose Escalation:
• •Histologically or cytologically confirmed diagnosis of 1 of the following:
• •* Small cell lung cancer (SCLC)
• •* Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features
• •* Non-pulmonary small cell carcinoma
• •* Metastatic carcinoid tumor
• •* Other CD56-positive solid tumor
• •Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry
• •Relapsed or refractory disease
• •Must have received at least 1 but no more than 3 prior chemotherapy regimens\* and recovered from any acute toxicities
• •* No prior chemotherapy for carcinoid or neuroendocrine tumors
• •DISEASE CHARACTERISTICS During MTD Expansion:
• •Relapsed or refractory Small cell lung cancer (SCLC)
• •Metastatic Merkel Cell carcinomas
• •Ovarian carcinomas
• •At the MTD:
• •SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen.
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• •No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure)
• •No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids.
• •PATIENT CHARACTERISTICS:
• •Life expectancy ≥ 3 months
• •ECOG performance status 0-2
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 10 g/dL
• •Creatinine ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 2.5 times ULN
• •Bilirubin ≤ 3 times ULN
• •No rapidly rising liver function tests (LFTs)
• •Pancreatic function, amylase and lipase within upper limit of normal.
• •No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy
• •No myocardial infarction within the past 6 months
• •No unstable angina pectoris
• •No uncontrolled congestive heart failure
• •No uncontrolled arrhythmia
• •No severe aortic stenosis
• •No history of multiple sclerosis or other demyelinating disease
• •No Eaton-Lambert syndrome (para-neoplastic syndrome)
• •No history of hemorrhagic stroke
• •No CNS injury with residual neurologic deficit
• •No ischemic stroke within the past 6 months
• •No history of pancreatitis
• •No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus
• •No other concurrent serious infection
• •No chronic alcoholism
• •No other concurrent illness or condition that would interfere with study outcome
• •No other malignancy within the past 3 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
• •No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Total cumulative dosage of prior anthracycline treatment must not exceed threshold for cardiotoxicity
• •No known hypersensitivity to previous monoclonal antibody therapy
• •More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
• •More than 4 weeks since prior and no other concurrent investigational agents
• •At least 4 weeks since prior and no concurrent surgery
• •No other concurrent antineoplastic treatment, including immunotherapy or steroid therapy