ADV/HSV-tk for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Houston Methodist Cancer Center, Houston, TX
Breast Cancer+5 More
ADV/HSV-tk - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of radiation and a virus can be used to treat cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Metastatic Breast Cancer, Triple Negative Breast Cancer
  • Metastatic Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ADV/HSV-tk will improve 1 primary outcome, 6 secondary outcomes, and 2 other outcomes in patients with Breast Cancer. Measurement will happen over the course of 30 days after the last dose of pembrolizumab.

Day 30
Antitumor activity
Clinical benefit rate
Duration of response
Number of participants with treatment-related adverse events
Objective response rate
Overall survival rate
Progression-free survival rate
Day 30
Change in immunohistochemical expression of tumor-infiltrating lymphocytes in tumor biopsy tissues
Computed tomography-based response of a non-target lesion

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Single arm
1 of 1
Experimental Treatment

This trial requires 57 total participants across 1 different treatment group

This trial involves a single treatment. ADV/HSV-tk is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Single armADV/HSV-tk (5 x 1011 virus particles) in a 2-mL total volume will be injected intratumorally on Day 0. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days from Day 1 to Day 15. SBRT of 30 Gy (6 Gy X 5 fractions) will be administered over 2 weeks from Day 2 to Day 16. Pembrolizumab (200 mg) will be administered intravenously over 30 minutes every 3 weeks starting on Day 17 and continuing until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valaciclovir
FDA approved
Pembrolizumab
FDA approved
SBRT
2013
Completed Phase 2
~550

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after the last dose of pembrolizumab
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days after the last dose of pembrolizumab for reporting.

Who is running the study

Principal Investigator
J. C. C.
Jenny C. Chang, MD
The Methodist Hospital Research Institute

Closest Location

Houston Methodist Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Platelets ≥100,000/µL
Hemoglobin ≥8 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
White blood cell count >2,500/µL and <15,000/µL
Willing and able to provide written informed consent/assent for the trial.
Male or female aged ≥18 years on the day of informed consent signing.
Histologically confirmed locally advanced or metastatic TNBC that has relapsed on or is refractory to standard of care therapy OR histologically or cytologically confirmed metastatic NSCLC that is immunotherapy and chemotherapy naïve or previously treated with 1 cycle of platinum-containing chemotherapy. Epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutation-negative NSCLC patients and NSCLC patients with EGFR or ALK genomic tumor aberrations that have failed FDA-approved targeted therapy for these aberrations will be eligible for enrollment in the study.
Measurable disease based on RECIST 1.1, a target lesion of suitable diameter (at least 1 cm) for SBRT, and a non-target lesion (visceral metastatic lesion) at least 1 cm in diameter for abscopal effect evaluation.
Willing to provide biopsy tissues as required by the study.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Absolute neutrophil count ≥1,500/µL (without granulocyte colony stimulating factor support within 14 days of assessment)

Patient Q&A Section

What are the signs of triple negative breast neoplasms?

"Most of the defining features of triple Negative Breast Neoplasms include the presence of the hormone receptor status of the tumor. Moreover, ER and PR are often overexpressive. Moreover, [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer)s are commonly associated with the presence of an axillary lymph node metastases." - Anonymous Online Contributor

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

"As part of the National Center for Health Statistics estimates for breast cancer-related deaths, 1,250 women will die of TNBC-related disease each year in the United States. The prognosis of TNBC is [extremely] poor compared with other breast cancers; it is one of the three most lethal forms of breast cancer(https://www.aad." - Anonymous Online Contributor

Unverified Answer

What are common treatments for triple negative breast neoplasms?

"Patients diagnosed with TNBC are treated with surgery, radiation therapy, or chemotherapy. There is no cure for this aggressive breast cancer, so surgeons must focus on maximizing the patient's chances of survival." - Anonymous Online Contributor

Unverified Answer

Can triple negative breast neoplasms be cured?

"Most triple negative breast cancers are low-grade. Lymphovascular space invasion (LVI) and multifocality are 2 powerful predictors of high-grade TNBC. In our series, only 3 (9.1%) of 41 patients with LVI-negative TNBC progressed. This finding is in stark contrast to the high prevalence of disease progression (48.2%) observed in our cohorts with multifocality-positive TNBC. LVI-negative patients with multifocal disease do well with multimodality treatment with surgery, trastuzumab, and adjuvant chemotherapy. As the percentage of low-grade TNBCs increases, so will the need for effective systemic therapy." - Anonymous Online Contributor

Unverified Answer

What causes triple negative breast neoplasms?

"The presence of a triple negative cancer is a new diagnosis for most menopausal women, and the [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is usually diagnosed after menopause. It is worthwhile to take a complete family history of breast cancer, menopause, menstrual disturbances, and endocrine treatment in all women with palpable breast masses, to be followed for many years." - Anonymous Online Contributor

Unverified Answer

What is triple negative breast neoplasms?

"TNBC has become an important subset of breast cancer, exhibiting unique clinicopathological characteristics, molecular features and survival. TNBC should be considered to be a high risk subtype of triple negative breast cancer and warrants attention in clinical practice." - Anonymous Online Contributor

Unverified Answer

How quickly does triple negative breast neoplasms spread?

"Although the median time from breast cancer diagnosis of the TNBC was found to be 5.6 years, there was a significant difference found between the spread from the first and second lymph nodes (about 2 and 3 years, respectively) and more specifically, the distant sites (4.1 years) after breast cancer diagnosis. In particular, the distant sites would have a great impact on the outcome of the patients. Thus, the patients are still at a significant risk of metastases within 8 months to 2 years after their breast cancer diagnosis which should be taken into account for a more adequate and individualized postoperative treatment." - Anonymous Online Contributor

Unverified Answer

What is adv/hsv-tk?

"Adv/HSV-tk has led to an anti-tumour effect. It has been combined with chemotherapies, such as docetaxel or doxorubicin. Adv/HSV-tk alone has also been investigated. It may be a successful monotherapy in certain circumstances. However, this treatment is not usually recommended as a first line regimen. It has also been studied as an adjunct therapy. The drug works by slowing tumour growth and relieving pain. The enzyme is part of a DNA repair mechanism." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets triple negative breast neoplasms?

"The mean age of diagnosis is 51 ± 12.5 years for triple negative breast cancer with 10% detected while still a child. The most prevalent histology is infiltrating ductal carcinoma, N0 lymph node, BRCA2 positive, while the most common tumors detected are invasive lobular carcinoma and invasive ductal carcinoma. In terms of treatment, 75% of cases require complete surgical removal." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of triple negative breast neoplasms?

"We identified that the BRAF, NRAS, and EGFR are the common mutations which caused TNBCs and could be important markers for further research. Future validation of BRAF, NRAS, and EGFR mutations could serve as markers for personalized therapy for TNBC." - Anonymous Online Contributor

Unverified Answer

Is adv/hsv-tk safe for people?

"In a recent study, findings supports previous data indicating that a single dose of Adv/HSV-tk is safe and efficacious for treatment of advanced cancer. Patients treated with these drugs reported the same symptoms as patients receiving a placebo. On the other hand, a dose response was observed in patients treated with the viral thymidine kinase protein. The adverse reactions noted in patients receiving this protein were less severe and transient than those reported in patients receiving a placebo, and none of them were life-threatening." - Anonymous Online Contributor

Unverified Answer

Does triple negative breast neoplasms run in families?

"A family history of TNBC appears to be present in an approximately 6% of women with TNBC, and should perhaps be considered, even in the absence of a family history of breast cancer, because of the possibility of the existence of a true high-risk genetic lesion for TNBC." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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