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Sponsored by: |
ImmunoGen, Inc. |
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Information provided by: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT00346385 |
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 |
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 |
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) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Relapsed or refractory disease
Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Paul C. Lorigan, MD | Christie Hospital NHS Foundation Trust |
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Thoracic Neoplasms Neuroectodermal Tumors, Primitive Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Sarcoma, Ewing's Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Ewing's Family of Tumors Carcinoid Syndrome Digestive System Neoplasms Serotonin Syndrome Malignant Carcinoid Syndrome |
Ewing's Sarcoma Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Malignant Mesenchymal Tumor Digestive System Diseases Lung Diseases Peripheral Neuroectodermal Tumor Sarcoma Non-small Cell Lung Cancer Gastrointestinal Neoplasms Carcinoid Tumor Adenocarcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Gastrointestinal Diseases Neoplasms, Nerve Tissue Malignant Carcinoid Syndrome Neuroendocrine Tumors Carcinoma Neoplasms, Connective and Soft Tissue Neuroectodermal Tumors Neoplasms |
Digestive System Diseases Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Sarcoma Gastrointestinal Neoplasms Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial |