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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.
• Treatments: Lorvotuzumab mertansine

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