Ovarian Cancer Clinical Trial
Immunotoxin Therapy in Treating Patients With Advanced Cancer
Summary
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.
Full Description
OBJECTIVES:
Primary
Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.
Secondary
Determine the response in patients treated with this drug.
Determine the plasma pharmacokinetics of this drug in these patients.
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 Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including one of the following:
Malignant mesothelioma
Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma
Tumors that may have originated in the bowel (e.g., appendiceal carcinoma) and involve the ovary
Ovarian cancers of other histology are eligible provided they express mesothelin
Pancreatic cancer
Squamous cell lung cancer
Squamous cell cancer of the head and neck
Squamous cell cancer of the cervix
Recurrent unresectable disease after prior standard anticancer therapy that was expected to prolong survival and improve quality of life OR unwilling to receive standard anticancer therapy
At least 30% of initial or recurrent tumor cells positive (at least 1+) for mesothelin by immunohistochemistry
Measurable or evaluable disease
No known CNS or spinal cord involvement
No clinically significant pericardial effusion
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
At least 12 weeks
Hematopoietic:
Absolute neutrophil count at least 1,000/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
Renal:
Creatinine no greater than ULN OR
Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min
Calcium no greater than ULN
Cardiovascular:
No New York Heart Association class II-IV heart disease
Pulmonary:
Oxygen saturation (SO_2) more than 92% on room air
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No detectable antibody to SS1(dsFv)-PE38
No infection requiring parenteral antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 1 week since prior hematopoietic growth factor therapy
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Other:
At least 4 weeks since any prior antitumor therapy and recovered
No other concurrent antitumor therapy
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There is 1 Location for this study
Bethesda Maryland, 20892, United States
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