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Mesothelioma Related Clinical Trials:
Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
Status: Completed
Sponsors and Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00066651
Condition: Cervical Cancer; Fallopian Tube Cancer; Head and Neck Cancer; Lung Cancer; Malignant Mesothelioma; Ovarian Cancer; Pancreatic Cancer; Peritoneal Cavity CancerCervical Cancer; Fallopian Tube Cancer; Head and Neck Cancer; Lung Cancer; Malignant Mesothelioma; Ovarian Cancer; Pancreatic Cancer; Peritoneal Cavity Cancer
Intervention: Drug: SS1(dsFv)-PE38 immunotoxin; Procedure: immunotoxin therapyProcedure: immunotoxin therapy
Purpose:
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.
| Study Type: Â | Interventional |
| Study Design: Â | Treatment, Open Label |
| Official Title: Â | Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing |
| Study Start Date: Â | July 2003 |
Detailed Description:
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies.
Secondary
- Determine the toxic effects of this drug in these patients.
- Determine the plasma pharmacokinetics of this drug in these patients.
- Determine the response in patients treated with this drug.
- Correlate the induction of antibody against this drug with its pharmacokinetics in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive a test dose of SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 4 weeks for up to 3 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 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-15 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 |
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed advanced malignancy of 1 of the following types:
- Ovarian cancer
- All nonmucinous epithelial histologies are eligible
- Primary peritoneal cavity cancer
- Fallopian tube cancer
- Malignant mesothelioma
- No sarcomatous histology
- Pancreatic cancer
- Squamous cell cancer (SCC) of the lung
- SCC of the cervix
- SCC of the head and neck
- Ovarian cancer
- Recurrent unresectable disease, meeting 1 of the following criteria:
- Previously treated with definitive standard therapy
- Patient refused prior standard therapy
- Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry* NOTE: *Immunohistochemical evaluation not required for patients with pancreatic cancer
- Measurable or evaluable disease
- No clinically significant pericardial effusion
- No known CNS or spinal cord involvement by tumor
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 75,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
- Albumin at least 3.0 g/dL
- Hepatitis B and C negative
- Seropositive allowed if clinically asymptomatic
- except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria
Renal
- Creatinine no greater than ULN
- Calcium no greater than ULN
Cardiovascular
- No New York Heart Association class II-IV cardiovascular disease
Pulmonary
- Oxygen saturation at least 93% on room air
- DLCO at least 50% of predicted*
- Total lung capacity and vital capacity at least 50% of predicted*
- FEV_1 at least 50% of predicted* NOTE: *For patients with pleural mesothelioma and as clinically indicated
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No infection requiring parenteral antibiotics
- No HIV infection
- Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75%
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4 weeks since prior therapy and recovered
- No other concurrent antitumor therapy
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066651Locations
| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support   | |||||
| Â Â Â Bethesda, Maryland, United States, 20892-1182 | |||||
| United States, North Carolina | |||||
| Comprehensive Cancer Center at Wake Forest University   | |||||
| Â Â Â Winston-Salem, North Carolina, United States, 27157-1096 | |||||
Sponsors and Collaborators
| National Cancer Institute (NCI) |
Investigators
| Study Chair: Â Â | Raffit Hassan, MD Â Â | National Cancer Institute (NCI) Â Â |
Additional Information:
| Study ID Numbers: Â | CDR0000316451, NCI-03-C-0243, NCI-6221, NCI-SS1PE-002 |
| First Received: Â | August 6, 2003 |
| Last Updated: Â | October 25, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00066651 |
| Health Authority: Â | United States: Federal Government |
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