|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University Hospital Freiburg |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010270 |
Purpose
RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer.
PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer |
Biological: LMB-9 immunotoxin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000068462, UFMC-431, UFMC-IND-7697, UFMC-NSC-691236, NCI-431, EU-20120 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00010270 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon stage III pancreatic cancer stage II pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV gastric cancer adenocarcinoma of the stomach |
recurrent gastric cancer adenocarcinoma of the esophagus stage IV esophageal cancer stage III esophageal cancer recurrent esophageal cancer stage II esophageal cancer adenocarcinoma of the rectum stage III colon cancer stage III rectal cancer stage III gastric cancer stage IV pancreatic cancer |
|
Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Esophageal Neoplasms Physiological Effects of Drugs Colonic Diseases Rectal Diseases Neoplasms by Site Stomach Diseases Stomach Neoplasms Endocrine Gland Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Endocrine System Diseases |
Intestinal Diseases Pharmacologic Actions Immunotoxins Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Pancreatic Diseases Esophageal Diseases Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |