Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
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.
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 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
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
- Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2015. Always confirm current availability with the study team.