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

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