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

NCT00346385 | Completed Phase 1

• 4 other identifiers: CDR0000491231IMMUNO-C10/IVB/002IMGN-002MDA-2004-0557
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 9

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 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.

Conditions

Ovarian Cancer; Merkel Cell Carcinoma; SCLC

Keywords

recurrent small cell lung cancer; merkel cell carcinoma; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments

  these tests will be conducted at various timepoints during a patients participation in the trial

Secondary Outcomes (2)

• Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level

  PK is assessed during the first cycle (21 days) of a patients participation

• Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)

  efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle

Interventions

BB-10901 DRUG

dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.

Also known as: IMGN901

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (9)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

The Ohio State University Cancer Center and Research Institute

Columbus, Ohio, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1023, United States

Location

Christie Hospital NHS Trust

Manchester, England, M20 9BX, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Merkel Cell; Small Cell Lung Carcinoma

Interventions

lorvotuzumab mertansine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul C. Lorigan, MD

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: March 1, 2002
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

US (6); GB (3)