Cervical CancerPhase 2NCT00003017
Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
A Phase 2 study testing recombinant interleukin-12 in people with Cervical Cancer, run by Eastern Cooperative Oncology Group at 9 sites in United States.
Trial summary
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells in the cervix. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- recombinant interleukin-12
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Jul 1997to Aug 2005
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven stage IV or recurrent squamous cell, adenosquamous, or adenocarcinoma of the uterine cervix including: Lung, liver, lymph node, or skin metastases OR Retroperitoneal disease OR Other advanced measurable disease OR Positive paraaortic lymph nodes Measurable disease that is beyond the scope of conventional radiation therapy or surgery, or recurrent after radiation therapy or surgery Measurable, recurrent disease within a previously irradiated field must have increased in size by 100% on at least 2 successive scans, MRI, or physical examinations
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III/IV heart disease No uncontrolled congestive heart failure or angina Pulmonary: No chronic obstructive pulmonary disease Gastrointestinal: No evidence of active gastrointestinal bleeding No active peptic ulcer disease No inflammatory bowel disease Other: Normal diet required No known active infections HIV negative AIDS-related complex (ARC) negative No substance abuse or psychiatric problems No evidence of autoimmune disease No other prior invasive malignancy except resected basal cell or squamous cell skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: 1 prior biologic therapy allowed At least 4 weeks since prior biologic therapy Chemotherapy: 1 prior adjuvant chemotherapy regimen allowed 1 prior chemotherapy regimen for advanced disease allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy No concurrent megestrol acetate Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
University of Rochester Cancer Center
Rochester, New York, 14642
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
About this study
Official title: Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells in the cervix.
PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix.
Read the detailed description
OBJECTIVES: I. Determine the response rates, duration of response, and survival in women with advanced, recurrent, or inoperable cervical cancer treated with interleukin-12. II. Determine the toxic effects of systemic interleukin-12 in these patients. III. Correlate response to therapy and survival with the presence or absence of human papilloma virus (HPV), and the specific subtype of HPV, in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (yes vs no). Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 78 patients (39 per stratum) will be accrued for this study within 26 months.
- Conditions
- Cervical Cancer
- Being tested
- recombinant interleukin-12
- Keywords
- stage IV cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interleukin-12Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2004 (estimated)
- Study startJul 1997
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scott Wadler, MD, Study chair, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003017
- Sponsor's protocol ID
- CDR0000065597
- Other IDs
- ECOG-E1E96
- Status last verified
- Jul 2004
- First submitted
- 1 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
Publications
Wadler S, Levy D, Frederickson HL, Falkson CI, Wang Y, Weller E, Burk R, Ho G, Kadish AS; Eastern Cooperative Oncology Group. A phase II trial of interleukin-12 in patients with advanced cervical cancer: clinical and immunologic correlates. Eastern Cooperative Oncology Group study E1E96. Gynecol Oncol. 2004 Mar;92(3):957-64. doi: 10.1016/j.ygyno.2003.12.022.
PubMed 14984966
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT00003017
- Acronym / sponsor ID
- CDR0000065597
- Conditions
- Cervical Cancer
- Keywords
- stage IV cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1997
- Study completion
- Aug 2005 (actual)
- First posted
- 22 Apr 2004 (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: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells in the cervix.
PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix.
Detailed description
OBJECTIVES: I. Determine the response rates, duration of response, and survival in women with advanced, recurrent, or inoperable cervical cancer treated with interleukin-12. II. Determine the toxic effects of systemic interleukin-12 in these patients. III. Correlate response to therapy and survival with the presence or absence of human papilloma virus (HPV), and the specific subtype of HPV, in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (yes vs no). Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 78 patients (39 per stratum) will be accrued for this study within 26 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| recombinant interleukin-12 | 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 21 Jun 2013.
- Results publication: PubMed 14984966Wadler S, Levy D, Frederickson HL, Falkson CI, Wang Y, Weller E, Burk R, Ho G, Kadish AS; Eastern Cooperative Oncology Group. A phase II trial of interleukin-12 in patients with advanced cervical cancer: clinical and immunologic correlates. Eastern Cooperative Oncology Group study E1E96. Gynecol Oncol. 2004 Mar;92(3):957-64. doi: 10.1016/j.ygyno.2003.12.022.
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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.
Scott Wadler, MD study chair
Albert Einstein College of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interleukin-12 in people with Cervical Cancer, run by Eastern Cooperative Oncology Group at 9 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00003017, which also lists 1 linked publication.
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 21 Jun 2013.