Ovarian Cancer Clinical Trial
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Summary
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.
Full 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 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
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
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There are 2 Locations for this study
Bethesda Maryland, 20892, United States
Winston-Salem North Carolina, 27157, United States
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