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AzTrials

Recurrent Fallopian Tube CancerPhase 1NCT01673217

Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

A Phase 1 study testing decitabine, NY-ESO-1 peptide vaccine and pegylated liposomal doxorubicin hydrochloride in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, run by Roswell Park Cancer Institute 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

This phase I trial is studying the side effects and best dose of decitabine when given together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
decitabine, NY-ESO-1 peptide vaccine and pegylated liposomal doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Apr 2009to Jun 2013
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with relapsed epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) who will receive liposomal doxorubicin as salvage therapy for recurrent disease
  • Patients may have received up to four previous lines of chemotherapy
  • The relapse may be defined by an increase in CA125; there may or may not be either measurable or symptomatic disease
  • Any human leukocyte antigen (HLA) type
  • No requirement for tumor expression of NY-ESO-1
  • Karnofsky performance status of > 70%
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  • Not previously treated with doxorubicin
  • Life expectancy >= 6 months
  • Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
  • No immunodeficiency
  • Have been informed of other treatment options
  • Able and willing to give valid written informed consent
  • Neutrophil count >= 1.5 x 10^9
  • Platelet count >= 100 x 10^9
  • Serum creatinine =< 2.1 mg/dL
  • Serum bilirubin =< 2 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.6 x upper limit of normal (ULN) (normal ranges: AST 15-46 U/L; ALT 11-66 U/L)

Who cannot join

  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available
  • Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
  • History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo
  • Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs; specific CQX-2 inhibitors are permitted
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study agent (6 weeks for nitrosoureas)
  • Known human immunodeficiency virus (HIV) positivity
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  • Known allergy or history of life threatening reaction to GM-CSF
  • Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
  • Lack of availability of a patient for immunological and clinical follow-up assessment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

This phase I trial is studying the side effects and best dose of decitabine when given together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with vaccine therapy may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety of 5-aza-2'-deoxycytidine (decitabine) in combination with immunization with NYESO-I protein mixed with montanide and granulocyte-macrophage colony stimulating factor (GM-CSF) in patients scheduled to receive liposomal doxorubicin for recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

SECONDARY OBJECTIVES:

  1. To evaluate NY-ESO-l specific cellular and humoral immunity by determination of NY-ESO-I specific antibody, CD8+ and CD4+ T-cells following immunization with NY-ESO-l protein mixed with montanide and GM-CSF in combination with 5-aza-2' -deoxycytidine (decitabine) in patients receiving liposomal doxorubicin for recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

II. To determine the impact of 5-aza-2'-deoxycytidine on NY-ESO-I specific expression, NY-ESO-l promoter methylation, and global DNA methylation.

III. To compare the time to progression (ttp) for the proposed therapy with the ttp for standard therapy (historical studies).

OUTLINE: This is a dose escalation study of decitabine.

Patients receive decitabine intravenously (IV) over 3 hours on day 1, pegylated liposomal doxorubicin hydrochloride IV on day 8, and NY-ESO-1 peptide vaccine emulsified in incomplete Freund's adjuvant and sargramostim subcutaneously on day 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 months.

Being tested
decitabine, NY-ESO-1 peptide vaccine, pegylated liposomal doxorubicin hydrochloride, sargramostim, incomplete Freund's adjuvant
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • decitabineDrug

    Also called 5-aza-dCyd, 5AZA, DAC

    Given IV

  • NY-ESO-1 peptide vaccineBiological

    Also called ESO-1 Peptide Vaccine

    Given SC

  • pegylated liposomal doxorubicin hydrochlorideDrug

    Also called CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposome

    Given IV

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given SC

  • incomplete Freund's adjuvantBiological

    Also called IFA, ISA-51, Montanide ISA 51

    Given SC

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • liquid chromatographyOther

    Also called LC

    Correlative studies

  • mass spectrometryOther

    Correlative studies

  • reverse transcriptase-polymerase chain reactionGenetic

    Also called RT-PCR

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • DNA methylation analysisGenetic

    Correlative studies

  • enzyme-linked immunosorbent assayOther

    Also called ELISA

    Correlative studies

Study groups in NCT01673217
Study groupRoleWhat they receive
Treatment (chemotherapy and vaccine therapy)ExperimentalPatients receive decitabine IV over 3 hours on day 1, pegylated liposomal doxorubicin hydrochloride IV on day 8, and NY-ESO-1 peptide vaccine emulsified in incomplete Freund's adjuvant and sargramostim subcutaneously on day 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: decitabine; Biological: NY-ESO-1 peptide vaccine; Drug: pegylated liposomal doxorubicin hydrochloride; Biological: sargramostim; Biological: incomplete Freund's adjuvant; Other: immunohistochemistry staining method; Other: liquid chromatography; Other: mass spectrometry; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Genetic: DNA methylation analysis; Other: enzyme-linked immunosorbent assay

What is being measured

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

  1. Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Estimated with a one-sided, 95%, Wilson score binomial confidence interval.

    Measured: Up to 6 months

Secondary outcomes (5)

  1. NY-ESO-1 specific cellular and humoral immunity as assessed by NY-ESO-1-specific CD8+ and CD4+ T cells and antibodies and frequency of CD4+ CD25+ FOXP3+ regulatory T cells

    Will be summarized by quartiles. Also, confidence intervals will be constructed for the median and the mean.

    Measured: Up to 6 months

  2. NY-ESO-l expression using Q-RT-PCR and IHC

    Measured: Days 1, 8, 15, 36, 43, 64, 71, 92, and 99

  3. Time to progression

    Summarized by a Kaplan-Meier survival curve.

    Measured: Up to 6 months

  4. NY-ESO-l promoter DNA methylation using pyrosequencing

    Measured: Days 1, 8, 15, 36, 43, 64, 71, 92, and 99

  5. Global genomic DNA methylation using liquid chromatography-mass spectrometry (LC-MS) and LINE-l pyrosequencing

    Measured: Days 1, 8, 15, 36, 43, 64, 71, 92, and 99

Timeline

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

  1. First posted27 Aug 2012 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2011
  4. Study completionJun 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673217
Sponsor's protocol ID
I 127008
Other IDs
NCI-2010-00105
Status last verified
Jul 2022
First submitted
22 Aug 2012
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing decitabine, NY-ESO-1 peptide vaccine and pegylated liposomal doxorubicin hydrochloride in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, run by Roswell Park Cancer Institute 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 17 inclusion and 11 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 1 Aug 2022. 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?

Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (time frame: Up to 6 months). 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 NCT01673217.

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 1 Aug 2022.

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