Anti-tumor B for Cancer

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical College of Wisconsin

Must not be taking: Herbal compounds

Disqualifiers: Pregnancy, Uncontrolled cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a window of opportunity study of Anti-tumor B (ATB). Anti-tumor B is a botanical agent composed of six Chinese herbs: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use any medicinal botanical, natural, or other herbal compounds while participating in the trial.

What data supports the idea that Anti-tumor B for Cancer is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Anti-tumor B for Cancer. Instead, it discusses other treatments and strategies, such as the use of Human Beta Defensin (hBD-1) in breast cancer and the effects of emodin and BTB14431 in colonic cancer. Without specific data on Anti-tumor B, we cannot conclude its effectiveness compared to other treatments. ^{1 2 3 4 5}

What safety data exists for Anti-tumor B (Zeng Sheng Ping) in cancer treatment?

The safety data for Anti-tumor B, also known as Zeng Sheng Ping, is limited in the provided research. The studies primarily focus on its efficacy in cancer prevention and treatment, particularly in inhibiting tumor growth and signaling pathways. However, specific safety data or adverse effects are not detailed in the abstracts provided. Further investigation into clinical trials or detailed studies would be necessary to obtain comprehensive safety data. ^{6 7 8 9 10}

Is Anti-tumor B a promising drug for cancer?

The information provided does not mention Anti-tumor B or its effects, so we cannot determine if it is a promising drug for cancer based on the given research articles. ^{11 12 13 14 15}

Research Team

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

Adults over 18 with a new or recurring oral cavity squamous cell cancer, who haven't had systemic chemotherapy for it. They must be fit for surgery and have good organ function. Women of childbearing age must use contraception, and men agree to barrier methods or abstinence.

Inclusion Criteria

- Potassium: > 3 mmol/L or < 6 mmol/L;

My kidney function, based on a formula, is within the required range.

I have a new or returning oral cancer after at least 6 months of remission.

Exclusion Criteria

I do not have severe health issues like uncontrolled heart disease or severe lung problems.

I am currently using herbal or natural remedies.

I have had chemotherapy for oral cancer but not for other cancers.

Treatment Details

Interventions

• Anti-tumor B
• Placebos

Trial Overview The trial is testing Anti-tumor B, made from six Chinese herbs, against a placebo in patients with oral cancer. It's randomized and double-blinded, meaning neither the doctors nor the patients know who gets the real treatment versus the placebo.

Participant Groups

Group I: Anti-tumor B Experimental Treatment 1 Intervention

1,200 mg three times a day.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

Human Beta Defensin (hBD-1) is a potential biomarker for breast cancer, particularly triple negative breast cancer (TNBC), as its loss is associated with tumor progression and resistance to chemotherapy.

The novel approach of A priori Activation of Apoptosis Pathways of Tumor (AAAPT) using hBD-1 in a TNBC mouse model demonstrated significant tumor volume reduction by sensitizing resistant cancer cells to the chemotherapy drug Doxorubicin, suggesting a way to enhance treatment efficacy while potentially reducing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of the Lost Human Beta Defensin (hBD-1) in Cancer as a Strategy to Improve the Efficacy of Chemotherapy. Pandurangi, RS., Sekar, TV., Paulmurugan, R.[2023]

In a study involving 100 rats with colon cancer, both low-dose BTB14431 and emodin significantly reduced total tumor weight when administered intravenously, indicating their potential as effective cancer treatments.

High-dose emodin also showed anti-cancer effects, particularly in reducing intraperitoneal tumor weight, while the optimal dosing for both compounds remains to be determined for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumorigenic Effects of Emodin and Its' Homologue BTB14431 on Vascularized Colonic Cancer in a Rat Model. Höhn, P., Braumann, C., Freiburger, M., et al.[2020]

In a rat model, both BTB14431 and emodin showed no significant tumor-suppressing effects when administered intraperitoneally or intravenously, despite previous in vitro evidence of their anti-tumor properties.

Higher doses of emodin were associated with an increased mortality rate, indicating potential safety concerns that need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependent role of novel agents emodin and BTB14431 in colonic cancer treatment in rats. Braumann, C., Koplin, G., Geier, C., et al.[2018]

Staphylococcal enterotoxin B (SEB) effectively increases the expression of the microRNA mir-335 in metastatic breast cancer cells, which may help inhibit metastasis, with significant results observed at both 24 and 48 hours after treatment.

Importantly, SEB showed no cytotoxic effects on the cancer cells, suggesting it could be a safe option for enhancing anti-tumor immune responses without harming healthy cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overexpression of Metastatic Related MicroRNAs, Mir-335 and Mir-10b, by Staphylococcal Enterotoxin B in the Metastatic Breast Cancer Cell Line. Heidary, MF., Mahmoodzadeh Hosseini, H., Mehdizadeh Aghdam, E., et al.[2020]

Triple negative breast cancer (TNBC) cells induce a significantly stronger immune response from natural killer (NK) cells compared to estrogen receptor-positive breast cancer cells, which may contribute to their aggressive nature.

In TNBC, there is a higher infiltration of regulatory T cells (Tregs) and increased expression of pAKT, suggesting that these tumors may utilize immune evasion strategies, highlighting the potential for immunomodulatory treatments in TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of tumor immune escape in triple-negative breast cancers (TNBC) with and without mutated BRCA 1. Engel, JB., Honig, A., Kapp, M., et al.[2018]

Zeng Sheng Ping (ZSP) effectively inhibits the growth of brain tumors in vitro by inducing apoptosis and down-regulating key components of the Notch signaling pathway, including Notch2 and Hes1.

In a mouse model with DAOY flank xenografts, ZSP treatment led to reductions in tumor mass and increased necrosis, suggesting potential therapeutic benefits, although these results were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Zeng Sheng Ping/ACAPHA on malignant brain tumor growth and Notch signaling. Lim, KJ., Rajan, K., Eberhart, CG.[2021]

The study identified three major compounds (fraxinellone, dictamnine, and maackiain) from the traditional Chinese medicine Zeng-Sheng-Ping (ZSP) that showed significant anti-proliferation activity against oral carcinoma cells, with lower IC50 values than ZSP itself.

An innovative activity and absorption-based platform was established to select these compounds as quality control markers for ZSP, ensuring that the pharmacological effects of the medicine are consistent and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an activity and absorption-based quality control platform for Chinese traditional medicine: Application to Zeng-Sheng-Ping(Antitumor B). Yin, T., Yang, G., Ma, Y., et al.[2022]

This study aims to systematically evaluate the efficacy and safety of Shen-Ling-Bai-Zhu-San (SLBZS) when used alongside chemotherapy for lung cancer treatment, addressing a gap in existing research.

The systematic review will analyze data from multiple databases and ongoing trials to provide comprehensive evidence on how SLBZS impacts treatment outcomes for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Shen-Ling-Bai-Zhu-San combined with chemotherapy for lung cancer: A protocol for systematic review and meta-analysis. Jiang, J., Li, Z., Zhang, F., et al.[2023]

BTMB, a novel derivative of Taiwanin A, effectively inhibits the growth of triple-negative breast cancer (TNBC) cells by inducing cell-cycle arrest and apoptosis, demonstrating its potential as an anticancer therapeutic agent.

The mechanism of action involves the suppression of key survival signaling pathways (Akt and ERK1/2) and the downregulation of cell-cycle regulatory proteins, leading to reduced cell proliferation and enhanced sensitivity to cisplatin in both in vitro and in vivo models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Inhibition of Key Proliferation Signaling Pathways in Triple-Negative Breast Cancer Cells by a Novel Derivative of Taiwanin A. Kuo, YH., Chiang, EI., Chao, CY., et al.[2021]

An aqueous extract of bamboo shavings (AE-BCT) significantly reduced the metastatic potential of cancer cells in laboratory studies, showing effectiveness in inhibiting cell migration, invasion, and adhesion, as well as suppressing MMP-9 activity.

In animal studies, daily oral administration of AE-BCT at doses of 50 and 100 mg/kg effectively inhibited lung metastasis of cancer cells without causing systemic toxicity, suggesting it may be a safe natural treatment option for metastatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous extract of Bambusae Caulis in Taeniam inhibits PMA-induced tumor cell invasion and pulmonary metastasis: suppression of NF-κB activation through ROS signaling. Kim, A., Im, M., Yim, NH., et al.[2021]

ACBP-S significantly inhibits the growth of human stomach cancer cells (MGC-803) in a concentration- and time-dependent manner, achieving an 86.6% inhibition rate at 20.0 microg/ml after 72 hours.

In a nude mouse model, ACBP-S treatment reduced tumor growth by 34.2% and increased apoptosis, suggesting its anti-cancer effects are linked to changes in cell cycle regulation and apoptosis mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of ACBP-S on cell cycle and apoptosis in human gastric cancer cells]. Su, XL., Ouyang, XH., Xu, GH., et al.[2011]

BPB-modified BthTX-I and its synthetic peptide showed significant antitumor activity, reducing tumor size by 30-36% at 14 days and 76-79% at 60 days in mice after tumor cell transplantation.

The study demonstrated that both the modified protein and the synthetic peptide exhibited cytotoxic effects on various tumor cell lines, suggesting their potential as effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effects of snake venom chemically modified Lys49 phospholipase A2-like BthTX-I and a synthetic peptide derived from its C-terminal region. Gebrim, LC., Marcussi, S., Menaldo, DL., et al.[2022]

ACBP, a novel bioactive peptide from goat spleens, effectively inhibits the proliferation of colorectal cancer (CRC) cells both in vitro and in vivo by targeting the Wnt/β-catenin signaling pathway.

The mechanism of action involves significantly reducing the expression of oncogenes like cyclin D1, met, and c-myc by compromising active β-catenin levels, which is achieved through the inhibition of phospho-LRP6 and stimulation of phospho-β-catenin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACBP suppresses the proliferation, migration, and invasion of colorectal cancer via targeting Wnt/beta-catenin signaling pathway. Tong, X., Zhuang, Z., Wang, X., et al.[2021]

(20S)-Protopanaxatriol (PPT), an active ginseng metabolite, shows promising anti-cancer effects in triple-negative breast cancer (TNBC) by inducing non-protective autophagy and apoptosis, which helps reduce cell proliferation and migration.

In vivo studies using xenograft mouse models demonstrated that PPT exerts its therapeutic effects by inhibiting the Akt/mTOR signaling pathway, suggesting it could be a potential treatment option for TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ginsenoside (20S)-protopanaxatriol induces non-protective autophagy and apoptosis by inhibiting Akt/mTOR signaling pathway in triple-negative breast cancer cells. Li, Y., Wang, P., Zou, Z., et al.[2021]

The anticancer bioactive peptide (ACBP) from goat spleens has shown significant potential in inhibiting gastric cancer cell growth and promoting apoptosis, indicating its promise as a biological anticancer drug.

GADD45A, a tumor suppressor gene, is essential for the effectiveness of ACBP, as downregulation of GADD45A in gastric cancer cells reduced their sensitivity to ACBP, suggesting it could serve as a biomarker for predicting response to this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticancer bioactive peptide (ACBP) inhibits gastric cancer cells by upregulating growth arrest and DNA damage-inducible gene 45A (GADD45A). Su, LY., Xin, HY., Liu, YL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Restoration of the Lost Human Beta Defensin (hBD-1) in Cancer as a Strategy to Improve the Efficacy of Chemotherapy. [2023]

2. Thailand pubmed.ncbi.nlm.nih.gov

Anti-tumorigenic Effects of Emodin and Its' Homologue BTB14431 on Vascularized Colonic Cancer in a Rat Model. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Dose-dependent role of novel agents emodin and BTB14431 in colonic cancer treatment in rats. [2018]

4. Iran pubmed.ncbi.nlm.nih.gov

Overexpression of Metastatic Related MicroRNAs, Mir-335 and Mir-10b, by Staphylococcal Enterotoxin B in the Metastatic Breast Cancer Cell Line. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Mechanisms of tumor immune escape in triple-negative breast cancers (TNBC) with and without mutated BRCA 1. [2018]

6. Greece pubmed.ncbi.nlm.nih.gov

Effects of Zeng Sheng Ping/ACAPHA on malignant brain tumor growth and Notch signaling. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Developing an activity and absorption-based quality control platform for Chinese traditional medicine: Application to Zeng-Sheng-Ping(Antitumor B). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Shen-Ling-Bai-Zhu-San combined with chemotherapy for lung cancer: A protocol for systematic review and meta-analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Dual Inhibition of Key Proliferation Signaling Pathways in Triple-Negative Breast Cancer Cells by a Novel Derivative of Taiwanin A. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Aqueous extract of Bambusae Caulis in Taeniam inhibits PMA-induced tumor cell invasion and pulmonary metastasis: suppression of NF-κB activation through ROS signaling. [2021]

11. China pubmed.ncbi.nlm.nih.gov

[Effect of ACBP-S on cell cycle and apoptosis in human gastric cancer cells]. [2011]

12. England pubmed.ncbi.nlm.nih.gov

Antitumor effects of snake venom chemically modified Lys49 phospholipase A2-like BthTX-I and a synthetic peptide derived from its C-terminal region. [2022]

13. France pubmed.ncbi.nlm.nih.gov

ACBP suppresses the proliferation, migration, and invasion of colorectal cancer via targeting Wnt/beta-catenin signaling pathway. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Ginsenoside (20S)-protopanaxatriol induces non-protective autophagy and apoptosis by inhibiting Akt/mTOR signaling pathway in triple-negative breast cancer cells. [2021]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Anticancer bioactive peptide (ACBP) inhibits gastric cancer cells by upregulating growth arrest and DNA damage-inducible gene 45A (GADD45A). [2021]