Breast CancerPhase 2NCT00319748

Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers

A Phase 2 study testing 852A in people with Breast Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Ovarian Cancer, Endometrial Cancer
What is being tested?: 852A
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Apr 2006to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Adequate performance status:
Breast - Karnofsky score > 50;
Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2
If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
Normal organ function within 14 days of study entry
Diagnosis of one of the following malignancies:

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Metastatic breast cancer (BR)
Metastatic ovarian cancer (OV)
Metastatic endometrial cancer (EM)
Metastatic cervical cancer (CX)
Breast Cancer Inclusion Criteria:
Measurable metastatic disease (>1cm) in at least one site other than bone-only
Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease
Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.
Ovarian Cancer Inclusion Criteria:
Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).
Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.
Endometrial Cancer Inclusion Criteria:
Measurable metastatic disease
Histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens
Cervical Cancer Inclusion Criteria:
Measurable metastatic disease
Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.

Who cannot join

Had/have the following prior/concurrent therapy:
Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
Investigational drugs/agents within 14 days of first dose of 852A
Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions
Radiotherapy within 3 weeks of the first dose of 852A

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Hematopoietic cell transplantation within 4 weeks of first dose of 852A
Evidence of active infection within 3 days of first dose of 852A
Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)
Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
Uncontrolled intercurrent or chronic illness
Active autoimmune disease requiring immunosuppressive therapy within 30 days
Active coagulation disorder not controlled with medication
Pregnant or lactating
Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated
Any history of brain metastases or any other active central nervous system (CNS) disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

Read the detailed description

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

Conditions: Breast Cancer, Ovarian Cancer, Endometrial Cancer, Cervical Cancer
Being tested: 852A
Keywords: Breast, Ovarian, Endometrial, Cervical, Metastatic, 852A, IRM, Oncology, Metastatic Cervical Cancer, Metastatic Ovarian Cancer, Metastatic Breast Cancer, Metastatic Endometrial Cancer
Medical subject headings: Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

852ADrug
Also called TLR-7, Toll-like receptor-7
0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.

Study groups in NCT00319748
Study group	Role	What they receive
Intent-To-Treat	Experimental	Patients treated with at least one dose - 852A subcutaneous injection. Receives: Drug: 852A
Evaluable Cohort	Experimental	Patients who received all 24 doses of 852A per protocol. Receives: Drug: 852A

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
Measured: after 12 weeks (24 doses of 852A)

Secondary outcomes (6)

Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 hours after Dose 1
Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Soluble CD40 Ligand (sCD40L)
Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Measured: Prior to Dose 1 and 6 Hours Post-Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Dec 2008

First posted27 Apr 2006 (estimated)
Study startApr 2006
Primary completionDec 2007
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Masonic Cancer Center, University of MinnesotaThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00319748
Sponsor's protocol ID: 06US03IMP-852A
Other IDs: MT2006-02, 2006LS005
Status last verified: Aug 2019
First submitted: 27 Apr 2006
Last updated: 26 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers
ClinicalTrials.gov ID: NCT00319748
Acronym / sponsor ID: 06US03IMP-852A
Conditions: Breast Cancer, Ovarian Cancer, Endometrial Cancer, Cervical Cancer
Keywords: Breast, Ovarian, Endometrial, Cervical, Metastatic, 852A, IRM, Oncology
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
Collaborators: Pfizer
Study start: Apr 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2008 (actual)
First posted: 27 Apr 2006 (estimated)
Results: Posted 25 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

Detailed description

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intent-To-Treat	Experimental	Drug: 852APatients treated with at least one dose - 852A subcutaneous injection.
Evaluable Cohort	Experimental	Drug: 852APatients who received all 24 doses of 852A per protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Adequate performance status:
If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
Normal organ function within 14 days of study entry
Diagnosis of one of the following malignancies:
Measurable metastatic disease (>1cm) in at least one site other than bone-only

Key exclusion criteria (17 listed)

Had/have the following prior/concurrent therapy:

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
852AAlso: TLR-7, Toll-like receptor-70.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.	Drug	Evaluable Cohort, Intent-To-Treat

Primary outcome

Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Time frame: after 12 weeks (24 doses of 852A)
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.

6 secondary outcomes

Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
Time frame: Prior to Dose 1 and 6 hours after Dose 1
Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Soluble CD40 Ligand (sCD40L)
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
Time frame: Prior to Dose 1 and 6 Hours Post-Dose

Results and safety

Results posted to the registry on 25 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With 852A	13	13

Primary outcome: Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.

Time frame: after 12 weeks (24 doses of 852A). Number. Unit: Participants

Measure	Patients With Ovarian Cancer n = 3
Complete Response	0
Partial Response	0
Stable Disease	1
Progressive Disease	2

Population analysed: Includes only patients that received all 24 doses of 852A.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Treated With 852A Study Drug	9 of 13 (69.2%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Other Adverse Events that occurred were noted as targeted toxicities and not captured as adverse events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Sarah Cooley, MD principal investigator

Masonic Cancer Center, University of Minnesota

Melissa A. Geller, MD principal investigator

Masonic Cancer Center, University of Minnesota

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 852A in people with Breast Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota 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 24 inclusion and 17 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 26 Aug 2019. 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?

Yes. Results are posted in the registry (first posted 25 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A. (time frame: after 12 weeks (24 doses of 852A)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00319748.

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 26 Aug 2019.