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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005858 |
RATIONALE: The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Breast Cancer Colorectal Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer |
Biological: LMB-9 immunotoxin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion |
Study Start Date: | April 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study within 12-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067885, MSGCC-9981, MSGCC-IRB-0200123, NCI-511 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005858 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Urinary Tract Neoplasm Immunologic Factors Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Breast Cancer, Male Ovarian Diseases Urologic Neoplasms Rectal Diseases Genital Diseases, Female Soft Tissue Sarcomas Respiratory Tract Diseases |
Urologic Diseases Lung Neoplasms Ovarian Cancer Bladder Neoplasm Breast Diseases Endocrine Gland Neoplasms Cystocele Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms |
Thoracic Neoplasms Immunologic Factors Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Physiological Effects of Drugs Colonic Diseases Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Rectal Diseases Genital Diseases, Female Neoplasms by Site Respiratory Tract Diseases Urologic Diseases |
Lung Neoplasms Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms Intestinal Diseases Pharmacologic Actions Immunotoxins |