- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066651
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157-1096
- Comprehensive Cancer Center at Wake Forest University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Raffit Hassan, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent non-small cell lung cancer
- recurrent metastatic squamous neck cancer with occult primary
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- recurrent pancreatic cancer
- squamous cell lung cancer
- recurrent ovarian epithelial cancer
- fallopian tube cancer
- recurrent malignant mesothelioma
- primary peritoneal cavity cancer
- cervical squamous cell carcinoma
- ovarian serous cystadenocarcinoma
- ovarian undifferentiated adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- salivary gland squamous cell carcinoma
- recurrent cervical cancer
- ovarian mixed epithelial carcinoma
- Brenner tumor
- ovarian carcinosarcoma
- epithelial mesothelioma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Adnexal Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Fallopian Tube Diseases
- Pancreatic Diseases
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Uterine Cervical Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Fallopian Tube Neoplasms
- Pancreatic Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Immunologic Factors
- Immunotoxins
Other Study ID Numbers
- CDR0000316451
- NCI-03-C-0243
- NCI-6221
- NCI-SS1PE-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on SS1(dsFv)-PE38 immunotoxin
-
National Cancer Institute (NCI)CompletedCervical Cancer | Head and Neck Cancer | Pancreatic Cancer | Ovarian Cancer | Fallopian Tube Cancer | Lung Cancer | Malignant Mesothelioma | Primary Peritoneal Cavity CancerUnited States
-
INSYS Therapeutics IncWithdrawn
-
INSYS Therapeutics IncWithdrawn
-
National Cancer Institute (NCI)CompletedPancreatic Neoplasms | Mesothelioma | Adenocarcinoma of LungUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)TerminatedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma | Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Completed