Cervical CancerPhase 1NCT00066651
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing SS1(dsFv)-PE38 immunotoxin in people with Cervical Cancer and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Fallopian Tube Cancer, Head and Neck Cancer
- What is being tested?
- SS1(dsFv)-PE38 immunotoxin
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jul 2003to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cancer, Fallopian Tube Cancer, Head and Neck Cancer, Lung Cancer, Malignant Mesothelioma, Ovarian Cancer
- Being tested
- SS1(dsFv)-PE38 immunotoxin
- Keywords
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Fallopian Tube Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Mesothelioma, Malignant, Ovarian Neoplasms, Pancreatic Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS1(dsFv)-PE38 immunotoxinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Raffit Hassan, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066651
- Sponsor's protocol ID
- CDR0000316451
- Other IDs
- NCI-03-C-0243, NCI-6221, NCI-SS1PE-002
- Status last verified
- Feb 2006
- First submitted
- 6 Aug 2003
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
- ClinicalTrials.gov ID
- NCT00066651
- Acronym / sponsor ID
- CDR0000316451
- Conditions
- Cervical Cancer, Fallopian Tube Cancer, Head and Neck Cancer, Lung Cancer, Malignant Mesothelioma, Ovarian Cancer
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2003
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS1(dsFv)-PE38 immunotoxin | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
Related trials for Cervical Cancer
Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
Not yet recruiting
Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)
Cervical Cancer Screening, Cervical Cancer
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffit Hassan, MD study chair
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SS1(dsFv)-PE38 immunotoxin in people with Cervical Cancer and Fallopian Tube Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.