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| Sponsor: | ImmunoGen, Inc. |
|---|---|
| Information provided by (Responsible Party): | 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 |
|---|---|---|
|
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 |
| Estimated Enrollment: | 44 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (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
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 |
DISEASE CHARACTERISTICS During Dose Escalation:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities
DISEASE CHARACTERISTICS During MTD Expansion:
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.
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Study Chair: | Paul C. Lorigan, MD | Christie Hospital NHS Foundation Trust |
More Information
| 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: | October 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent small cell lung cancer merkel cell carcinoma ovarian cancer |
|
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 |