CompletedPhase 1NCT00066651

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

StatusCompleted
PhasePhase 1
U.S. locations2
SponsorNational Cancer Institute (NCI)
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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