NCT00373217

Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Terminated Phase 2 Results posted Last updated 21 September 2022

What this trial tests

Phase 2 trial testing MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine in Fallopian Tube Cancer in 6 participants. Terminated before completion.

Timeline

13 April 2006

Primary endpoint
7 February 2008

7 February 2008

Quick facts

Lead sponsor	Craig L Slingluff, Jr
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	13 April 2006
Primary completion	7 February 2008
Estimated completion	7 February 2008
Sites	1 location across United States

Drugs / interventions tested

• MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine — full drug profile →
• tetanus toxoid helper peptide — full drug profile →
• carboplatin (Carboplatin) — full drug profile →
• paclitaxel — full drug profile →
• conventional surgery

Conditions studied

• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
• Ovarian Cancer — all drugs for Ovarian Cancer →
• Primary Peritoneal Cavity Cancer — all drugs for Primary Peritoneal Cavity Cancer →

Sponsor

Craig L Slingluff, Jr — full company profile →

Who can join

Adults 18 to 120, female only, with Fallopian Tube Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cytotoxic T-cell Response to Vaccine Therapy Comprising 5 Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Course 1 Primary · through week 3

T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation

Group	Value	95% CI
Group 1: Adjuvant	1
Group 2: Neoadjuvant	1

Cytotoxic T-cell Response to Vaccine Therapy Comprising Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Chemotherapy and During Course 2 Secondary · weeks 4-28 for group 1, week 4-16 for group 2

T cell response to one or more peptides in peripheral blood by IFN-gamma ELIspot assay during chemotherapy and/or during 2nd course of vaccines.

Group	Value	95% CI
Group 1: Adjuvant	2
Group 2: Neoadjuvant	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after last study intervention, up to 18 months after enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: Adjuvant

Serious: 0/3 (0%)

Deaths: 0/3

Group 2: Neoadjuvant

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (1 terms — click to expand)

Reaction	System	Group 1: Adjuvant	Group 2: Neoadjuvant
injection site reaction	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT00373217 adverse events section.

Sponsor's own description

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving vaccine therapy and chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for stage III or stage IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anti-HER2 vaccines: new prospects for breast cancer therapy.
   Ladjemi MZ, Jacot W, Chardès T, Pèlegrin A, et al · · 2010 · cited 103× · PMID 20532501 · DOI 10.1007/s00262-010-0869-2
2. Identifying novel SMYD3 interactors on the trail of cancer hallmarks.
   Fasano C, Lepore Signorile M, De Marco K, Forte G, et al · · 2022 · cited 14× · PMID 35495117 · DOI 10.1016/j.csbj.2022.03.037
3. The progress of peptide vaccine clinical trials in gynecologic oncology.
   Tang M, Cai JH, Diao HY, Guo WM, et al · · 2022 · cited 13× · PMID 35687860 · DOI 10.1080/21645515.2022.2062982
4. The expression of cancer-testis antigen in ovarian cancer and the development of immunotherapy.
   Zhao J, Xu Z, Liu Y, Wang X, et al · · 2022 · cited 9× · PMID 35261795