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

NCT ID: NCT00346385

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2011-10-31

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.

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 drug in these patients.
• Determine 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

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 40 patients are treated at the MTD.

After completion of study treatment, patients are followed for short term and long term follow up and survival.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.

Conditions

Ovarian Cancer; Merkel Cell Carcinoma; SCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BB-10901

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

Intervention Type: DRUG

Other Intervention Names

IMGN901

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmunoGen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul C. Lorigan, MD

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Locations

University of California San Francisco

San Francisco, California, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

The Ohio State University Cancer Center and Research Institute

Columbus, Ohio, United States

Oklahoma University

Oklahoma City, Oklahoma, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Christie Hospital NHS Trust

Manchester, England, United Kingdom

Cancer Research Centre at Weston Park Hospital

Sheffield, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Countries

United States; United Kingdom

Other Identifiers

IMMUNO-C10/IVB/002

Identifier Type: -

Identifier Source: secondary_id

IMGN-002

Identifier Type: -

Identifier Source: secondary_id

MDA-2004-0557

Identifier Type: -

Identifier Source: secondary_id

CDR0000491231

Identifier Type: -

Identifier Source: org_study_id

NCT00625287

Identifier Type: -

Identifier Source: nct_alias