Primary Peritoneal Cavity CancerPhase 2NCT00016289
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase 2 study testing recombinant interleukin-12 in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
- What is being tested?
- recombinant interleukin-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2007
- 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
Who may be able to join
- Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma
- Surgically documented disease after prior platinum-based chemotherapy with or without surgery
- Minimal residual disease, defined as metastases less than 1 cm in largest diameter
- No significant adhesions or symptoms of obstruction
- No extra-abdominal or parenchymal disease
- No more than 6 weeks since prior primary chemotherapy
Show all 31Show fewer
- Performance status - Zubrod 0-1
- Absolute granulocyte count greater than 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Lymphocyte count greater than 600/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2.5 times upper limit of normal
- Albumin at least 3.0 g/dL
- Hepatitis B and C negative
- Creatinine no greater than 1.5 mg/dL
- No significant cardiac disease
- No significant pulmonary disease
- No overt autoimmune disease
- No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer
- HIV negative
- Successful placement of peritoneal catheter
- No prior immunotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No concurrent chemotherapy
- No chronic steroid therapy
- No prior radiotherapy
- See Disease Characteristics
- Recovered from prior surgery
- At least 2 weeks since prior laparoscopy
- At least 4 weeks since prior laparotomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma
Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells
Read the detailed description
OBJECTIVES:
- Determine the response rate and progression-free interval in patients with peritoneal carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma treated with intraperitoneal interleukin-12.
II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology, conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in patients treated with this regimen.
IV. Assess quality of life in patients treated with this regimen. V. Determine the pharmacology and pharmacokinetics of this drug in these patients.
VI. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
VII. Determine whether this regimen decreases expression of vascular endothelial growth factor, fibroblast growth factor 2, and interleukin-8 as surrogate markers of angiogenesis and whether a decrease in marker expression is associated with clinical activity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. Quality of life is assessed at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of their disease response; and then 2 weeks later. Patients are followed every 2 months for 1 year and then every 3 months for 1 year.
- Being tested
- recombinant interleukin-12
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interleukin-12Biological
Also called cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor
Given intraperitoneally
| Study group | Role | What they receive |
|---|---|---|
| Treatment (recombinant interleukin-12) | Experimental | Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. Receives: Biological: recombinant interleukin-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of remission determined by laparoscopy or laparotomy
Tested using an exact test for a single binomial proportion
Measured: Up to 2 years
Toxicity graded using the NCI CTC version 3.0
Evaluated for each dose level and each course of therapy.
Measured: Up to 2 years
Progression-free interval
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Peritoneal Cavity 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Renato Lenzi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016289
- Sponsor's protocol ID
- NCI-2012-02381
- Other IDs
- MDA-ID-00232, N01CM17003, CDR0000068619
- Status last verified
- Jan 2013
- First submitted
- 6 May 2001
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00016289
- Acronym / sponsor ID
- NCI-2012-02381
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2001
- Primary completion
- Jul 2007 (actual)
- First posted
- 27 Jan 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.
Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells
Detailed description
OBJECTIVES:
- Determine the response rate and progression-free interval in patients with peritoneal carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma treated with intraperitoneal interleukin-12.
II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology, conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in patients treated with this regimen.
IV. Assess quality of life in patients treated with this regimen. V. Determine the pharmacology and pharmacokinetics of this drug in these patients.
VI. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
VII. Determine whether this regimen decreases expression of vascular endothelial growth factor, fibroblast growth factor 2, and interleukin-8 as surrogate markers of angiogenesis and whether a decrease in marker expression is associated with clinical activity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. Quality of life is assessed at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of their disease response; and then 2 weeks later. Patients are followed every 2 months for 1 year and then every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (recombinant interleukin-12) | Experimental | Biological: recombinant interleukin-12Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma
- No significant adhesions or symptoms of obstruction
- No extra-abdominal or parenchymal disease
- No more than 6 weeks since prior primary chemotherapy
- Performance status - Zubrod 0-1
Key exclusion criteria (0 listed)
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-12Also: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factorGiven intraperitoneally | Biological | Treatment (recombinant interleukin-12) |
Primary outcome
Rate of remission determined by laparoscopy or laparotomy
Time frame: Up to 2 years
Tested using an exact test for a single binomial proportion
Toxicity graded using the NCI CTC version 3.0
Time frame: Up to 2 years
Evaluated for each dose level and each course of therapy.
Progression-free interval
Time frame: Up to 2 years
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 23 Jan 2013.
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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.
Renato Lenzi principal investigator
M.D. Anderson Cancer Center
1 site 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 Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site 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?
The sponsor lists 31 inclusion and 0 exclusion criteria. 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Rate of remission determined by laparoscopy or laparotomy (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 23 Jan 2013.