A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms

Thank you

Trial Information

A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer


Patients with epithelial ovarian, fallopian tube or peritoneal cancer who receive surgical
cytoreduction and platinum/taxane containing chemotherapy have a significant chance of
entering complete clinical remission but about 70% will eventually relapse. Many patients
respond to additional cytotoxic treatment with partial or complete responses, yet
approximately 100% of these patients will ultimately progress. Novel consolidation
strategies following treatment for recurrent disease are needed and an immunologic approach
is an attractive option.


Inclusion Criteria:



- Patients with epithelial carcinoma arising in the ovary, fallopian tube or
peritoneum, stages I-IV. These patients must have received initial surgery and
chemotherapy with at least one platinum based chemotherapy regimen.

- Patients must have relapsed and now have completed chemotherapy for recurrent disease
within the last 6 weeks.

- Eligible patients may have asymptomatic residual measurable disease on CT scan,
and/or may have an elevated CA-125, or may be in complete clinical remission.

- Patients must have adequate hematologic, renal and hepatic functions.

Exclusion Criteria:

- Patients with any other active malignancy concomitantly

- Patients within 3 weeks of prior cytotoxic or investigational chemotherapy

- Patients within 4 weeks of prior radiotherapy

- Patients within 6 weeks of prior immunotherapy

- Patients who have received any prior anti-cancer vaccine

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety, feasibility and tolerability

Principal Investigator

Jacobus Pfisterer, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO Study Group

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

AGO-OVAR 2.8

NCT ID:

NCT00103545

Start Date:

July 2003

Completion Date:

August 2004

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Ovarian Cancer
  • ACA 125
  • 6 or 9 vaccinations
  • immune response
  • Fallopian tube cancer
  • Peritoneal cancer
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

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