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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006981 |
Purpose
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for advanced cancer.
PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Fallopian Tube Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Ovarian Cancer Pancreatic Cancer Peritoneal Cavity Cancer |
Biological: SS1(dsFv)-PE38 immunotoxin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days |
| Study Start Date: | December 2000 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SS1(dsFv)-PE38 immunotoxin IV continuously on days 1-10. Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including one of the following:
Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Robert Kreitman, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000068351, NCI-01-C-0011, NCI-6249 |
| Study First Received: | December 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006981 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage III cervical cancer recurrent cervical cancer stage IVB cervical cancer stage IVA cervical cancer squamous cell lung cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer advanced malignant mesothelioma recurrent malignant mesothelioma stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent metastatic squamous neck cancer with occult primary |
ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma cervical squamous cell carcinoma metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx |
|
Thoracic Neoplasms Immunologic Factors Neoplasms, Mesothelial Gonadal Disorders Pancreatic Neoplasms Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Antibodies, Monoclonal Genital Diseases, Female Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Peritoneal Diseases Endocrine Gland Neoplasms |
Respiratory Tract Neoplasms Digestive System Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Pharmacologic Actions Immunotoxins Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Neoplasms Digestive System Diseases Lung Diseases |