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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT00346385
First received: June 28, 2006
Last updated: April 22, 2013
Last verified: April 2013
  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
Ovarian Cancer
Merkel Cell Carcinoma
SCLC
Drug: BB-10901
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments [ Time Frame: these tests will be conducted at various timepoints during a patients participation in 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: PK is assessed during the first cycle (21 days) of a patients participation ] [ 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: efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2002
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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.
    Other Name: IMGN901
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346385

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94115
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Ohio
The Ohio State University Cancer Center and Research Institute
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1023
United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 9BX
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Chair: Paul C. Lorigan, MD Christie Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00346385     History of Changes
Obsolete Identifiers: NCT00625287
Other Study ID Numbers: CDR0000491231, IMMUNO-C10/IVB/002, IMGN-002, MDA-2004-0557
Study First Received: June 28, 2006
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
recurrent small cell lung cancer
merkel cell carcinoma
ovarian cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Merkel Cell
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 15, 2014