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Breast CancerPhase 1NCT00381173

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

A Phase 1 study testing Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing) in people with Breast Cancer and Ovarian Cancer, run by Eisai Inc. at 2 sites 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 feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Ovarian Cancer, Prostate Cancer
What is being tested?
Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
Nov 2006to Oct 2008
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in the study, patients must meet the following criteria:
  • Patients with:
  • Advanced stage malignancies who have failed treatment, including at least one, but no more than two, prior regimens of chemotherapy: Ovary, Breast, Colon, Hormone Refractory Prostate Cancer (HRPC), and renal.
  • Evidence of measurable disease by clinical or radiographic assessment or by tumor biomarker (ovarian and prostate cancer).
  • Age ≥ 18 years old.
  • A baseline Eastern Cooperative Oncology Group Performance Status of 0 or 1.
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  • A life expectancy > 6 months.
  • Adequate hematological function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
  • Absolute lymphocyte count ≥ 1,000/mm^2
  • WBC ≥ 3,000/mm^2
  • Platelet count ≥ 75,000/mm^2
  • Hemoglobin ≥ 9 g/dL
  • Adequate renal function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as serum creatinine ≤ 1.5 X upper limit of normal.
  • Adequate hepatic function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
  • Total bilirubin ≤ 1.5 X upper limit of normal, and
  • SGOT and SGPT ≤ 2.5X upper limit of normal.
  • An MRI of the brain, if clinically indicated, which is negative for parenchymal central nervous system metastases within 28 days prior to receipt of the first dose of cyclophosphamide. If a patient cannot undergo an MRI because of a medical contraindication, a contrast CT of the brain will be acceptable.
  • A negative pregnancy test (blood or urine) within 14 days prior to first dose of cyclophosphamide (where applicable).
  • Agree to use appropriate contraception from study entry until the end-of-observation visit.
  • A signed informed consent form approved by the Institutional Review Board.

Who cannot join

  • Patients cannot participate in the study if any of the following apply:
  • Have a history of parenchymal brain metastases.
  • Have received any of the following within 28 days prior to receiving the first dose of cyclophosphamide:
  • Chemotherapy
  • Radiation therapy
  • Immunotherapy
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  • Systemic immunosuppressive drugs
  • Glucocorticoids (inhalers for asthma are permitted)
  • Investigational agent or experimental therapy
  • Have received three or more biologic/targeted therapies, such as monoclonal antibodies and tyrosine kinase inhibitors.
  • Have initiated or reinitiated the use of hormonal agents within 28 days prior to receiving the first dose of cyclophosphamide. These drugs are allowed if treatment was initiated greater than 28 days prior to receipt of the first dose of cyclophosphamide.
  • Have a history of bone marrow or stem cell transplantation.
  • Have a history of treatment with fludarabine, 2-chlorodeoxyadenosine, 2-deoxycoformycin or similar compounds.
  • Have a history of treatment with chronic systemic immunosuppressive drugs.
  • Have an immunologic disorder such as immunodeficiency or other chronic auto-immune disease if deemed to be clinically significant.
  • Have an active systemic infection requiring treatment.
  • Are known to be positive for HIV antibody.
  • Pregnant or lactating.
  • Have a history of alcohol abuse, illicit drug use, or psychiatric disorder that would in the Investigator's opinion jeopardize protocol compliance or compromise the patient's ability to give informed consent.
  • Have had prior ex vivo or in vivo DNA therapy (administration of viral vectors or plasmid DNA formulations) or cancer vaccines.
  • Previous exposure to ZYC300 or amolimogene (HPV E6E7 plasmid; formerly known as ZYC101a).
  • Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • M. D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing

The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).

Read the detailed description

This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies (cancerous growths) of the ovary, breast, colon, or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy. Patients who meet all entry criteria will be administered 600 mg/m^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles. This is the first time that ZYC300 and Cyclophosphamide will be given together. Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer. In this trial the study drug will be used to boost the immune system. Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells. The T reg cells limit the immune systems attack on infected or abnormal cells. In this study, the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells.

Being tested
Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)
Keywords
MGI PHARMA, ZYC3-002, ZYC300, plasmid DNA, cyclophosphamide, Cytoxan, advanced breast cancer, advanced ovarian cancer, hormone refractory prostate cancer, advanced colon cancer, advanced renal cancer, advanced stage malignancies, immune therapy, gene therapy, biologic therapy, T-regulatory cells, cancer vaccine, vaccine, Advanced stage malignancies-ovary, breast, colon, prostate
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Kidney Neoplasms

What participants receive

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

  • Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)Drug

    Patients who meet all entry criteria will be administered 600 mg/m^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

Study groups in NCT00381173
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)

What is being measured

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

  1. Determine the feasibility, safety and tolerability of administering ZYC300 intramuscularly every other wk for 6 doses (400 micrograms DNA/total dose) to the study pop. pre-dosed with 600 mg/m^2 cyclophosphamide intravenously 3 days prior to study drug.

    Measured: Within 14 days and 12 weeks post last dose of study drug (and 16 weeks post last dose for response confirmation, if applicable).

Secondary outcomes (1)

  1. Assess the effect of cyclophosphamide on T reg number and function. Assess the generation of CYP1B1-specific immun. as a result of vac. regimen. Assess the effect of vac. regimen on tumor response, if any, in pat. pop.

    Measured: Within the first 14 days and at each subsequent visit.

Timeline

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

  1. First posted27 Sep 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00381173
Sponsor's protocol ID
ZYC3-002
Status last verified
Jul 2011
First submitted
26 Sep 2006
Last updated
14 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Gribben JG, Ryan DP, Boyajian R, Urban RG, Hedley ML, Beach K, Nealon P, Matulonis U, Campos S, Gilligan TD, Richardson PG, Marshall B, Neuberg D, Nadler LM. Unexpected association between induction of immunity to the universal tumor antigen CYP1B1 and response to next therapy. Clin Cancer Res. 2005 Jun 15;11(12):4430-6. doi: 10.1158/1078-0432.CCR-04-2111.

    PubMed 15958627

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing) in people with Breast Cancer and Ovarian Cancer, run by Eisai Inc. at 2 sites 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 20 inclusion and 22 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Determine the feasibility, safety and tolerability of administering ZYC300 intramuscularly every other wk for 6 doses (400 micrograms DNA/total dose) to the study pop. pre-dosed with 600 mg/m^2 cyclophosphamide intravenously 3 days prior to study drug. (time frame: Within 14 days and 12 weeks post last dose of study drug (and 16 weeks post last dose for response confirmation, if applicable).). 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 NCT00381173, which also lists 1 linked publication.

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 14 May 2013.

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