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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00381173

NCT00381173
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have advanced cancer (ovarian, breast, colon, prostate that no longer responds to hormones, or kidney cancer) that has come back or stopped responding to treatment, and you have tried at least one but no more than two chemotherapy treatments before.
  • Your cancer can be measured or tracked — either through scans, physical examination, or blood markers (for ovarian or prostate cancer).
  • You are 18 years of age or older.
  • You are in generally good physical condition and able to carry out daily activities with no more than mild limitations (confirm with trial site).
  • Your doctor estimates you have more than 6 months to live.
  • Your blood cell counts are at healthy enough levels, checked within 14 days before starting treatment (confirm specific values with trial site).
  • Your kidneys are working well enough, based on a blood test taken within 14 days before starting treatment.
  • Your liver is working well enough, based on blood tests taken within 14 days before starting treatment.
  • A brain scan (MRI or CT scan if MRI is not possible) taken within 28 days before starting treatment shows no cancer has spread to the brain tissue.
  • You have a negative pregnancy test (blood or urine) within 14 days before starting treatment, if this applies to you.
  • You agree to use appropriate birth control from the start of the study until your final follow-up visit.
  • You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

  • You have a history of cancer that has spread into the brain tissue.
  • You have received chemotherapy, radiation, immunotherapy, immune-suppressing drugs, steroids (other than asthma inhalers), or any experimental treatment within the past 28 days.
  • You have previously received three or more targeted or biological therapies, such as monoclonal antibodies or certain targeted cancer drugs.
  • You started or restarted hormonal therapy within the past 28 days.
  • You have previously had a bone marrow or stem cell transplant.
  • You have previously been treated with certain specific immune-suppressing drugs, including fludarabine or similar medications (confirm with trial site).
  • You have a history of long-term use of immune-suppressing medications.
  • You have an immune system disorder, such as an immunodeficiency condition or a significant chronic autoimmune disease.
  • You currently have an active infection that requires treatment.
  • You are known to be HIV positive.
  • You are pregnant or breastfeeding.
  • You have a history of alcohol abuse, illegal drug use, or a psychiatric condition that the trial doctor feels could affect your ability to follow the study rules or give informed consent.
  • You have previously received any gene therapy using viral or DNA-based treatments, or any cancer vaccine.
  • You have previously been treated with a specific experimental drug called ZYC300 or amolimogene.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Eisai Inc.
Registry
clinicaltrials_gov
Start date
1 November 2006
Est. completion
1 October 2008

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov