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Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer

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Trial Information

Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion


OBJECTIVES:

I. Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced
colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer.

II. Assess the toxicity and pharmacokinetics of this treatment regimen in these patients.

III. Determine the clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30
days 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 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 weeks and then every 2 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced colon, breast, non-small cell
lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for
which no effective standard therapy exists

- Expresses Lewis Y antigen

- Evidence of disease progression

- B3 antigen on the surface of more than 30% of the tumor cells determined by
immunohistochemistry

- No neutralizing antibodies to LMB-9 immunotoxin

- No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Male or female

Performance status:

- ECOG 0-1

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute granulocyte count greater than 1,200/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases
allowed)

- Albumin at least 3.0 g/dL

- No prior liver disease (e.g., alcohol liver disease)

- Hepatitis B and C negative

Renal:

- Creatinine no greater than 1.4 mg/dL

- Creatinine clearance greater than 60 mL/min

- Proteinuria less than 1 g/24 hours

Cardiovascular:

- No history of coronary artery disease

- No cardiac arrhythmia requiring therapy

- No New York Heart Association class II-IV congestive heart failure

Pulmonary:

- Pulmonary function test required if significant smoking history, possible pulmonary
disease, or lung cancer

- FEV1 and FVC at least 65% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known seizure disorders

- No urinary tract infection

- No other concurrent malignancy

- No active peptic ulcer disease

- No known allergy to omeprazole

- No contraindication to pressor therapy

- No other concurrent medical or psychological condition that would preclude study

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
recovered

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Judith E. Karp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067885

NCT ID:

NCT00005858

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • recurrent non-small cell lung cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • recurrent colon cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • ovarian stromal cancer
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • male breast cancer
  • stage IV pancreatic cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms

Name

Location

Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182