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| Sponsor: | 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 Ovarian Cancer Merkel Cell Carcinoma 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: | June 2010 |
| Estimated Primary Completion Date: | January 2010 (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.
Eligibility| 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:
Contacts and Locations| United States, Ohio | |
| The Ohio State University Cancer Center and Research Institute | Recruiting |
| Columbus, Ohio, United States | |
| Contact: M. Villalona, MD 866-627-7616 osu@emergingmed.com | |
| 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 |
More Information
| Responsible Party: | ImmunoGen, Inc. ( Clinical Operations ) |
| Study ID Numbers: | CDR0000491231, IMMUNO-C10/IVB/002, IMGN-002, MDA-2004-0557 |
| Study First Received: | June 28, 2006 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00346385 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent small cell lung cancer merkel cell carcinoma ovarian 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 Carcinoma, Neuroendocrine Gonadal Disorders Neoplasms, Nerve Tissue Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Neuroendocrine Tumors Carcinoma Adnexal Diseases Carcinoma, Merkel Cell Neuroectodermal Tumors Neoplasms Lung Diseases Sarcoma Adenocarcinoma Neoplasms, Glandular and Epithelial |