Recurrent Ovarian Epithelial CancerPhase 1NCT00004032
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
A Phase 1 study testing ALVAC-hB7.1, recombinant interferon gamma and laboratory biomarker analysis in people with Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Ovarian Epithelial Cancer
- What is being tested?
- ALVAC-hB7.1, recombinant interferon gamma and laboratory biomarker analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Apr 2004
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of ovarian epithelial carcinoma
- Previously treated with an adequate course of platinum based chemotherapy
- Evidence of intraabdominal disease
- No significant adhesions
- Performance status - Zubrod 0-2
- Lymphocyte count at least 500/mm^3
Show all 19Show fewer
- Bilirubin no greater than 1.5 mg/dL
- SGOT less than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- No major disorder of the cardiovascular system
- No major disorder of the pulmonary system
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Successful placement of peritoneal catheter
- No overt autoimmune disease
- No concurrent chronic steroid therapy
- No prior radiotherapy
- Prior surgery allowed
- Recovered from prior therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer
Read the detailed description
OBJECTIVES:
- Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.
OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.
Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
- Conditions
- Recurrent Ovarian Epithelial Cancer
- Being tested
- ALVAC-hB7.1, recombinant interferon gamma, laboratory biomarker analysis
- 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.
ALVAC-hB7.1Biological
Given IP
recombinant interferon gammaBiological
Also called Actimmune, gamma interferon, IFN-G
Given IP
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ALVAC-hB7.1, recombinant interferon gamma) | Experimental | Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Receives: Biological: ALVAC-hB7.1; Biological: recombinant interferon gamma; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autologous tumor cell cytotoxicity lymphocyte (CTL)
Measured: Up to 7 years
Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR
Measured: Up to 7 years
Toxicity as assessed by NCI Common Terminology Criteria (CTC)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2003 (estimated)
- Study startOct 1997
- Primary completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian Epithelial 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ralph Freedman, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004032
- Sponsor's protocol ID
- NCI-2012-02255
- Other IDs
- MDA-ID-96253, U01CA062461, CDR0000065850
- Status last verified
- Jan 2013
- First submitted
- 10 Dec 1999
- 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
- Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
- ClinicalTrials.gov ID
- NCT00004032
- Acronym / sponsor ID
- NCI-2012-02255
- Conditions
- Recurrent Ovarian Epithelial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 1997
- Primary completion
- Apr 2004 (actual)
- First posted
- 25 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.
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer
Detailed description
OBJECTIVES:
- Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.
OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.
Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ALVAC-hB7.1, recombinant interferon gamma) | Experimental | Biological: ALVAC-hB7.1, Biological: recombinant interferon gamma, Other: laboratory biomarker analysisPatients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of ovarian epithelial carcinoma
- Previously treated with an adequate course of platinum based chemotherapy
- Evidence of intraabdominal disease
- No significant adhesions
- Performance status - Zubrod 0-2
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 |
|---|---|---|
| ALVAC-hB7.1Given IP | Biological | Treatment (ALVAC-hB7.1, recombinant interferon gamma) |
| recombinant interferon gammaAlso: Actimmune, gamma interferon, IFN-GGiven IP | Biological | Treatment (ALVAC-hB7.1, recombinant interferon gamma) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (ALVAC-hB7.1, recombinant interferon gamma) |
Primary outcome
Autologous tumor cell cytotoxicity lymphocyte (CTL)
Time frame: Up to 7 years
Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR
Time frame: Up to 7 years
Toxicity as assessed by NCI Common Terminology Criteria (CTC)
Time frame: 3 weeks
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.
Ralph Freedman 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 1 study testing ALVAC-hB7.1, recombinant interferon gamma and laboratory biomarker analysis in people with 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 19 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 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.
What does the primary outcome measure?
Autologous tumor cell cytotoxicity lymphocyte (CTL) (time frame: Up to 7 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.