Immunotoxin Therapy In Treating Patients With Advanced Solid Tumors

Study Overview

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.

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.

Cervical Cancer
Fallopian Tube Cancer
Head and Neck Cancer
Lung Cancer
Malignant Mesothelioma
Ovarian Cancer
Pancreatic Cancer
Primary Peritoneal Cavity Cancer

BIOLOGICAL: SS1(dsFv)-PE38 immunotoxin

CDR0000316451
NCI-03-C-0243
NCI-6221
NCI-SS1PE-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-08-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-04-29
First Submitted that Met QC Criteria 2003-08-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-04-30
First Posted (ESTIMATED) 2003-08-07	Results First Posted N/A	Last Verified 2006-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-2

At least 12 weeks

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 75,000/mm^3

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

Creatinine no greater than ULN
Calcium no greater than ULN

No New York Heart Association class II-IV cardiovascular disease

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

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%

Not specified

Not specified

Not specified

Not specified

Not specified

At least 4 weeks since prior therapy and recovered
No other concurrent antitumor therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Raffit Hassan, MD, National Cancer Institute (NCI)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record