NCT00179309

A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC(Trademark)-V (Vaccinia) and PANVAC(Trademark)-F (Fowlpox) in Adults With Metastatic Breast Cancer

Completed Phase 2 Results posted Last updated 30 June 2014

What this trial tests

Phase 2 trial testing Docetaxel in Breast Cancer in 48 participants. Completed in 1 October 2013.

Timeline

1 September 2005

Primary endpoint
1 February 2013

1 October 2013

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 September 2005
Primary completion	1 February 2013
Estimated completion	1 October 2013
Sites	2 locations across United States

Drugs / interventions tested

• Docetaxel (Docetaxel) — full drug profile →
• PANVAC-V — full drug profile →
• PANVAC-F — full drug profile →
• Sargramostim (SARGRAMOSTIM) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 85, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free Survival (PFS)
  Time frame: 19.7 months
  Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new me

Sponsor's own description

This study will test whether giving a combination of a vaccine together with docetaxel is more effective against breast cancer than docetaxel alone. The Food and Drug Administration has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists of three parts: 1) a "priming vaccine" called PANVAC (PAN (all) VAC (vaccine)) trademark \[TM\]-V, which is made from vaccinia virus; 2) a "boosting vaccine" called PANVAC\[TM\]-F, made from fowlpox virus; and 3) sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF), a protein that may help boost the immune system. Human genes are inserted into the vaccinia and fowlpox viruses to cause production of carcinoembryonic antigen (CEA) and mucin 1 (MUC-1)-two proteins that are often produced by cancer cells and can be used as a target for the immune system to attack the cancer. Another type of deoxyribonucleic acid (DNA) is inserted to cause production of other proteins that enhance immune activity.

Patients 18 years of age or older with metastatic breast cancer (disease that has spread beyond the original site) and whose cancer produces CEA or mucin 1 (MUC-1) protein may be eligible for this study. Patients must have antigen type human leukocyte antigen A2 (HLA-A2). They may have received adjuvant docetaxel treatment at least 3 months before entering this study, prior hormonal therapy and up to three chemotherapy regimens. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, and computerized tomography (CT) or magnetic resonance imaging scans.

Participants are randomly assigned to one of two treatment groups - docetaxel alone or docetaxel plus vaccine - as follows:

Docetaxel Alone

All patients receive docetaxel. The drug is infused through a vein over 30 to 60 minutes once a week for 3 consecutive weeks with 1 week off drug. Patients also take dexamethasone 12 hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention (edema) that docetaxel may cause.

Docetaxel Plus Vaccine

Participants receive the priming vaccination followed by monthly boosting vaccinations, along with the weekly docetaxel therapy. With every vaccination, patients also receive an injection of sargramostim to increase the number of immune cells at the vaccination site. Sargramostim injections are given the day of vaccination and daily for the next 3 days. All vaccine and sargramostim doses are given as injections under the skin, usually in the thigh. Patients are observed in the clinic for 1 hour after each injection.

Patients have blood tests every four weeks to monitor drug side effects and before every vaccination to check blood counts. A bone scan or CT scan (or both) is done every 2 to 3 months to check the response to treatment.

Patients may continue receiving treatment as long as their disease does not worsen and they can tolerate the treatment without significant side effects. Patients assigned to receive docetaxel alone whose disease progresses after 3 months on the drug may choose to receive the vaccine or come off the study to receive other treatment options. Patients are monitored with yearly telephone calls for up to 15 years.

Publications & conference data

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

1. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
2. Tumor evasion from T cell surveillance.
   Töpfer K, Kempe S, Müller N, Schmitz M, et al · · 2011 · cited 116× · PMID 22190859 · DOI 10.1155/2011/918471
3. Antigen-specific vaccines for cancer treatment.
   Tagliamonte M, Petrizzo A, Tornesello ML, Buonaguro FM, et al · · 2014 · cited 109× · PMID 25483639 · DOI 10.4161/21645515.2014.973317
4. Elevated serum soluble CD40 ligand in cancer patients may play an immunosuppressive role.
   Huang J, Jochems C, Talaie T, Anderson A, et al · · 2012 · cited 102× · PMID 22932804 · DOI 10.1182/blood-2012-05-427799
5. Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial.
   Heery CR, Ibrahim NK, Arlen PM, Mohebtash M, et al · · 2015 · cited 78× · PMID 26291768 · DOI 10.1001/jamaoncol.2015.2736
6. Vaccinia viruses: vaccines against smallpox and vectors against infectious diseases and tumors.
   Walsh SR, Dolin R. · · 2011 · cited 70× · PMID 21854314 · DOI 10.1586/erv.11.79
7. The future of cancer immunotherapy: DNA vaccines leading the way.
   Pandya A, Shah Y, Kothari N, Postwala H, et al · · 2023 · cited 53× · PMID 37294501 · DOI 10.1007/s12032-023-02060-3
8. Breast Cancer Vaccines: Disappointing or Promising?
   Zhu SY, Yu KD. · · 2022 · cited 52× · PMID 35154149 · DOI 10.3389/fimmu.2022.828386