Clinical trial · Interventional

LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer

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

NCT00005858CI-TRIAL-00041447completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer. The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
LMB-9 immunotoxin	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Biological: LMB-9 immunotoxin

Primary outcomes (0)

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Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Apr 1, 2000
Primary completion: Dec 1, 2003
Completion: Dec 1, 2003
First posted: Jan 27, 2003
Last update posted: Nov 4, 2019
Enrollment: 25 (actual)
Lead sponsor: University of Maryland, Baltimore OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Data updated 22 days agoSource updated Nov 4, 2019source: clinicaltrials

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