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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter Hafkemeyer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kreiskrankenhaus Emmendingen

Authority:

United States: Federal Government

Study ID:

CDR0000068462

NCT ID:

NCT00010270

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms

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