Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066651
First received: August 6, 2003
Last updated: April 23, 2011
Last verified: February 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Cervical Cancer
Head and Neck Cancer
Lung Cancer
Mesothelioma
Ovarian Cancer
Pancreatic Cancer
Sarcoidosis
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | July 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066651
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Raffit Hassan, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00066651 History of Changes |
| Obsolete Identifiers: | NCT00065481 |
| Other Study ID Numbers: | CDR0000316451, NCI-03-C-0243, NCI-6221, NCI-SS1PE-002 |
| Study First Received: | August 6, 2003 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
ovarian carcinosarcoma ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer Brenner tumor primary peritoneal cavity cancer fallopian tube cancer epithelial mesothelioma recurrent malignant mesothelioma recurrent pancreatic cancer |
cervical squamous cell carcinoma recurrent cervical cancer recurrent non-small cell lung cancer squamous cell lung cancer recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent metastatic squamous neck cancer with occult primary recurrent salivary gland cancer salivary gland squamous cell carcinoma recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Head and Neck Neoplasms Lung Neoplasms Mesothelioma Ovarian Neoplasms Pancreatic Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Digestive System Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013