Status:
COMPLETED
BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
Lead Sponsor:
ImmunoGen, Inc.
Conditions:
Ovarian Cancer
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ca...
Detailed Description
OBJECTIVES: Primary * Determine the safety and tolerability of BB-10901 * Determine the maximum tolerated dose of this drug in these patients. Secondary * Determine the pharmacokinetics of this dr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00346385
Start Date
March 1 2002
End Date
October 1 2011
Last Update
March 26 2015
Active Locations (9)
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1
University of California San Francisco
San Francisco, California, United States, 94115
2
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
3
The Ohio State University Cancer Center and Research Institute
Columbus, Ohio, United States
4
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104