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BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
This study is currently recruiting participants.
Verified by ImmunoGen, Inc., January 2009
Sponsored by: ImmunoGen, Inc.
Information provided by: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00346385
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Gastrointestinal Carcinoid Tumor
Lung Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BB-10901
Phase I

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901

Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
  • Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2002
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BB-10901
    dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and tolerability of BB-10901 in patients with relapsed or refractory small cell lung cancer, other pulmonary tumors of neuroendocrine origin, non-pulmonary small cell carcinoma, metastatic carcinoid tumors, or other CD56-positive solid tumors.
  • Determine the maximum tolerated dose of this drug in these patients.

Secondary

  • Determine the pharmacokinetics of this drug in these patients.
  • Determine, preliminarily, 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 for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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 12 patients are treated at the MTD.

After completion of study treatment, patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

    • Relapsed disease is defined as disease that initially responded (partial or complete response) to first-line therapy and then relapsed more than 3 months after completion of the last chemotherapy regimen
    • Refractory disease is defined as disease that failed to respond to last chemotherapy regimen OR that relapsed within 3 months after completion of the last chemotherapy regimen
  • 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
    • No more than 1 prior chemotherapy regimen for patients recruited to further explore the maximum tolerated dose of BB-10901 NOTE: * Chemotherapy-naive patients with carcinoid or neuroendocrine tumors are allowed.
  • 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 known CNS metastases

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 normal limits.
  • 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 5 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 prior 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346385

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
United Kingdom, England
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Penella J. Woll, MD, PhD     44-114-226-5206        
Christie Hospital NHS Trust Recruiting
Manchester, England, United Kingdom, M20 9BX
Contact: Paul C. Lorigan, MD     44-161-446-3755     paul.lorigan@christie-tr.nwest.nhs.uk    
Royal Marsden NHS Foundation Trust - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary O'Brien, MD     44-20-8661-3276     mary.o'brien@rmh.nhs.uk    
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Chair: Paul C. Lorigan, MD Christie Hospital NHS Foundation Trust
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: ImmunoGen, Inc. ( Clinical Operations )
Study ID Numbers: CDR0000491231, IMMUNO-C10/IVB/002, IMMUNO-002, MDA-2004-0557
Study First Received: June 28, 2006
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00346385  
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
recurrent small cell lung cancer
recurrent non-small cell lung cancer
pulmonary carcinoid tumor
unspecified adult solid tumor, protocol specific
recurrent gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
cervical small cell carcinoma
recurrent cervical cancer
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Study placed in the following topic categories:
Thoracic Neoplasms
Neuroectodermal Tumors, Primitive
Gastrointestinal Diseases
Ewing's family of tumors
Malignant mesenchymal tumor
Soft tissue sarcomas
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Non-small cell lung cancer
Digestive System Neoplasms
Serotonin Syndrome
Malignant Carcinoid Syndrome
Carcinoid syndrome
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoid tumor
Carcinoma, Small Cell
Neuroectodermal Tumors
Digestive System Diseases
Peripheral neuroectodermal tumor
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Carcinoid Tumor

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 14, 2009