Immunotoxin Therapy in Treating Patients With Advanced Cancer
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.
Checked against the public recordLast updated Apr 30, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Biological: SS1(dsFv)-PE38 immunotoxin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2015. Always confirm current availability with the study team.