• Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
• Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

• Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level
• Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)

RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.

OBJECTIVES:

Primary

• Determine the safety and tolerability of BB-10901 in patients with relapsed or refractory small cell lung cancer, other pulmonary tumors of neuroendocrine origin, non-pulmonary small cell carcinoma, metastatic carcinoid tumors, or other CD56-positive solid tumors.
• Determine the maximum tolerated dose of this drug in these patients.

Secondary

• Determine the pharmacokinetics of this drug in these patients.
• Determine, preliminarily, the efficacy of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board.

Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 12 patients are treated at the MTD.

After completion of study treatment, patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

• Cervical Cancer
• Ovarian Cancer
• Merkel Cell Carcinoma
• Lung Cancer
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

DISEASE CHARACTERISTICS:

• 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

  • Relapsed disease is defined as disease that initially responded (partial or complete response) to first-line therapy and then relapsed more than 3 months after completion of the last chemotherapy regimen
  • Refractory disease is defined as disease that failed to respond to last chemotherapy regimen OR that relapsed within 3 months after completion of the last chemotherapy regimen

• 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
  • No more than 1 prior chemotherapy regimen for patients recruited to further explore the maximum tolerated dose of BB-10901 NOTE: * Chemotherapy-naive patients with carcinoid or neuroendocrine tumors are allowed.
• 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 known CNS metastases

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 normal limits.
• 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 5 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 prior 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