Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT00065429
First received: July 23, 2003
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: BB-10901
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I) [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
    Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.

  • Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions


Enrollment: 64
Study Start Date: April 2003
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BB-10901, 5mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 10 mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 20 mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 40 mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 60 mg/m2 - Phase I & Phase II
Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II.
Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 67.5 mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
Experimental: BB-10901, 75 mg/m2 - Phase I Drug: BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.

Detailed Description:

The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).

  Eligibility

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

Inclusion:

  • Histologically or Cytologically proven SCLC, CD 56+ small cell carcinoma of unknown origin, or CD56+ non-pulmonary small cell carcinoma
  • Relapsed disease; defined as patients with an initial response (partial or complete) to first-line therapy, then relapse more than 3 months after completion of last chemotherapy.
  • Patients must have received no more than 3 prior chemotherapy regimen.
  • Patients must have measurable disease defined as: Lesions that can be measured in at least one dimension according to RECIST
  • Predicted survival of 3 months or more
  • Zubrod performance status 0-2
  • Patients must not have received chemotherapy or radiation therapy within 4 weeks of study entry, nor have planned surgery.
  • Absolute neutrophils greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 9g/dl and platelets greater than or equal to 100 x 10^9/l.
  • Creatinine less than or equal to 1.5 times the upper limit of normal
  • AST/ALT less than or equal to 3 times the upper limit of normal without liver metastases; less than or equal to 5 times the upper limit of normal with liver metastases and bilirubin less than or equal to 1.5 times the upper limit of normal.
  • Patients must have normal thyroid function (patients receiving thyroxin replacement therapy who are biochemically euthyroid may be enrolled).
  • Women of childbearing potential must provide a negative pregnancy test at screening and use adequate contraception in the opinion of the investigator, for the duration of study.
  • Patients must be capable of understanding the nature of the trial and must give written witnessed informed consent prior to any screening procedure.

Exclusion:

  • Significant residual neurological or cardiac toxicity (grade 3 or 4) following previous chemotherapy
  • Patients who are concurrently receiving other anti-neoplastic treatment (chemotherapy, radiotherapy, or immunotherapy including steroid therapy).
  • Myocardial infarction within 6 months of study entry, unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled arrythmia, severe aortic stenosis, a history of multiple sclerosis, or other demyelinating disease, Eaton-Lambert Syndrome, history of hemorrhagic stroke, any CNS injury with residual neurologic deficit, ischaemic stroke within the last 6 months, current known herpes zoster (shingles), or cytomegalovirus infection, or a history of recurrent infections with these viruses, chronic alcoholism, serious concomitant infection, or any other concomitant illness considered significant enough to interfere with the study outcome.
  • Other investigational agents must not be taken during the study or within 4 weeks of study entry.
  • Previous monoclonal antibody therapy
  • Patients must not have known central nervous system metastases
  • Previous malignancy with < 5 year disease free interval from the last therapeutic intervention, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Patient unwilling or unable to tolerate and comply with the requirements of the study.
  • Pregnant or lactating females.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00065429

Locations
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Cancer Center of Florida
Ocoee, Florida, United States, 34761
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01107
United States, New York
New York Oncology Hematology
Albany, New York, United States, 12208
United States, Ohio
The Ohio State University
Colombus, Ohio, United States, 43221
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-7095
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00065429     History of Changes
Obsolete Identifiers: NCT00074256
Other Study ID Numbers: C10/IVB/001
Study First Received: July 23, 2003
Results First Received: August 3, 2011
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 01, 2014