LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
Recruitment status was Active, not recruiting
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the clinical response of patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
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:
- Histologically or cytologically confirmed advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach that is refractory to standard treatment
- Overexpression of the Lewis-Y antigen
- Measurable or evaluable disease
- No CNS metastasis
- Metastatic liver disease from primary tumor allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,200/mm^3
Hepatic:
- Bilirubin normal
- SGOT and SGPT no greater than 1.5 times upper limit of normal
- Hepatitis B or C antigen negative
- No liver disease (e.g., alcohol liver disease)
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Creatinine clearance at least 60 mL/min
- Proteinuria no greater than 1 g/24 hours (grade II toxicity-like)
Cardiovascular:
- No prior coronary artery disease
- No New York Heart Association class II, III, or IV congestive heart failure
- No arrhythmia requiring treatment
Pulmonary:
- FEV_1 and FVC greater than 65% predicted
Other:
- No other concurrent malignancy
- No active peptic ulcer disease
- No known allergy to omeprazole
- No known seizure disorder
- No concurrent medical or psychiatric condition that would preclude study participation
- No contraindication to pressor therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010270 History of Changes |
| Other 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 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Rectal Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Head and Neck Neoplasms Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Immunotoxins Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013