BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
Ovarian Cancer, Merkel Cell Carcinoma, SCLC
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent small cell lung cancer, merkel cell carcinoma, ovarian cancer
Eligibility 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
Sites / Locations
- University of California San Francisco
- Nevada Cancer Institute
- The Ohio State University Cancer Center and Research Institute
- Oklahoma University
- M. D. Anderson Cancer Center at University of Texas
- Fred Hutchinson Cancer Research Center
- Christie Hospital NHS Trust
- Cancer Research Centre at Weston Park Hospital
- Royal Marsden NHS Foundation Trust - Surrey