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Recurrent Fallopian Tube CarcinomaPhase 2NCT02948101

PD 0360324 and Cyclophosphamide in Treating Patients With Recurrent High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 study testing Anti-CSF1 Monoclonal Antibody PD-0360324, Cyclophosphamide and Laboratory Biomarker Analysis in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies the side effects of PD 0360324 and cyclophosphamide and to see how well they work in treating patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Anti-CSF1 Monoclonal Antibody PD-0360324, Cyclophosphamide and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
31 Dec 2018to 6 Feb 2019
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

  • Written informed consent
  • Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer
  • Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined at least two lesions that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be > 20 mm when measured by palpitation or >10 mm when measured by spiral computed tomography (CT), plain x-ray, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT; PET/CT will be acceptable at baseline if PET/CT was previously performed and available; imaging must be performed within -28 to -7 days of starting therapy; the target lesion must be distinct from other tumor areas selected for pre-treatment biopsies
  • Subject must be willing to undergo protocol directed biopsies and blood draw for immune profiling
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Life expectancy of >= 4 months in the attending physician's estimation
  • Estimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula
  • White blood cell (WBC) >= 3.0 x 10^3/ul
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (> 1500 per mm^3)
  • Platelet count >= 100 x 10^9/L (> 100,000 per mm^3)
  • Hemoglobin >= 9.0 g/dL
  • Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >=60 years old and no menses for > 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
  • Subject must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
  • Signed informed consent for protocol PA13-0291

Who cannot join

  • Absence of a biopsiable lesion as determined by radiologist
  • Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer in the last 21 days
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of study drug and of low potential risk for recurrence;
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or
  • Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ
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  • Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324, with the exceptions of intranasal and inhaled corticosteroids and systemic corticosteroids at physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)
  • Prior immunotherapy with immune checkpoint inhibitors
  • Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)
  • Subjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participation
  • Subjects with existing periorbital edema
  • Subjects with aspartate aminotransferase (AST) or alanine transaminase (ALT) >= 2 x upper limit of normal (ULN)
  • Subjects with creatine kinase > ULN
  • Subjects with clinically significant active ischemic heart disease, cardiac muscle disease (including cardiomyopathy or congestive heart failure) or myodegenerative disorders that may affect safe study participation
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days prior to study entry
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (e.g., Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab)
  • Pregnant or breastfeeding women or women of child-bearing potential who are not willing to use two highly effective methods of contraception (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence)
  • Uncontrolled intercurrent illness including, but not limited to, bowel obstruction, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), tuberculosis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent, or undergo study procedures
  • History of leptomeningeal carcinomatosis or brain metastasis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Pilot Study of the Pre-Conditioning Effects of Anti-Macrophage Therapy Using PD 0360324 in Recurrent Platinum-Resistant Epithelial Ovarian Cancer

This phase II trial studies the side effects of PD 0360324 and cyclophosphamide and to see how well they work in treating patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement. Immunotherapy with monoclonal antibodies, such as PD 0360324, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cyclophosphamide may stop the growth of disease by blocking the growth of new blood vessels necessary for tumor growth. Giving PD 0360324 and cyclophosphamide may work better in treating patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the safety of anti-CSF1 monoclonal antibody PD-0360324 (PD 0360324) followed by cyclophosphamide in patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers.

II. To examine the density of CD8+ T cells in tumor biopsies before and after PD 0360324.

SECONDARY OBJECTIVES:

  1. To evaluate response rate and progression free survival associated with low dose oral cyclophosphamide after PD 0360324 treatment.

II. To evaluate M-CSF concentrations before and after treatment with PD 0360324 and during cyclophosphamide therapy.

TERTIARY OBJECTIVES:

  1. To evaluate the immunologic effects of PD 0360324 on peripheral blood and ovarian cancer tissue.

II. To explore the relationships between drug concentration and immunologic biomarkers and response.

OUTLINE:

Patients receive anti-CSF1 monoclonal antibody PD 0360324 intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Starting on day 43, patients receive cyclophosphamide orally (PO) once daily (QD). Courses with cyclophosphamide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 and 90 days.

Being tested
Anti-CSF1 Monoclonal Antibody PD-0360324, Cyclophosphamide, Laboratory Biomarker Analysis
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • Anti-CSF1 Monoclonal Antibody PD-0360324Biological

    Also called Anti-M-CSF mAb PD-0360324, PD 0360324, PD 360324, PD-0360324

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02948101
Study groupRoleWhat they receive
Treatment (PD 0360324, cyclophosphamide)ExperimentalPatients receive anti-CSF1 monoclonal antibody anti-CSF1 monoclonal antibody PD 0360324 IV over 30 minutes on days 1, 8, 15, and 22. Starting on day 43, patients receive cyclophosphamide PO QD. Courses with cyclophosphamide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Anti-CSF1 Monoclonal Antibody PD-0360324; Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Incidence of adverse effect

    Measured: Up to 90 days

  2. Density of CD8+ T cells in tumor biopsies

    Will be reported descriptively at each time point. Continuous measures will be presented with nonparametric methods such as median and interquartile range or boxplots, while correlations (Pearson's or Spearman's as indicated) will be calculated with other continuous measures. Scored or categorical measures will be tabulated.

    Measured: Up to 90 days

  3. Response rate

    Will be reported with a 95% confidence interval.

    Measured: Up to 90 days

  4. Progression-free survival

    Will be presented with a Kaplan-Meier curve.

    Measured: Up to 90 days

  5. Concentration-time data of PD 0360324

    Will be summarized by descriptive statistics (n, mean, standard deviation, median, minimum, and maximum).

    Measured: Up to 90 days

Timeline

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

  1. First posted28 Oct 2016 (estimated)
  2. Study start31 Dec 2018 (estimated)
  3. Primary completion6 Feb 2019
  4. Study completion6 Feb 2019

Why it stopped: PI's request

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02948101
Sponsor's protocol ID
2016-0053
Other IDs
NCI-2016-01928, 2016-0053, P30CA016672
Status last verified
Mar 2019
First submitted
25 Oct 2016
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-CSF1 Monoclonal Antibody PD-0360324, Cyclophosphamide and Laboratory Biomarker Analysis in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by M.D. Anderson Cancer Center 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 15 inclusion and 19 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: withdrawn, as of the sponsor's last update on 12 Mar 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of adverse effect (time frame: Up to 90 days). The study lists 5 primary outcomes in all. 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 NCT02948101.

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 12 Mar 2019.

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