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

Duration: 1-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new botanical treatment, Anti-tumor B, made from six Chinese herbs, to determine its effectiveness in treating squamous cell cancer (SCC) of the mouth. The goal is to understand how this treatment affects the cancer and whether it could be a beneficial option for patients. Individuals newly diagnosed with oral SCC or those with a recurrent case after being cancer-free for at least six months may be suitable for this study. Participants will take 1,200 mg of Anti-tumor B three times a day. As an Early Phase 1 trial, the study focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that Anti-tumor B is likely to be safe for humans?

Research has shown that Anti-tumor B, also known as Zeng Sheng Ping, is derived from six Chinese herbs. It has been tested for its effects on certain cancers, such as those of the esophagus and mouth. However, limited information exists regarding its safety for humans. Most studies have focused on its efficacy rather than potential side effects.

This trial is in its early phase, indicating that the treatment is still in the initial stages of human testing. Early phase trials typically have less safety information. Nonetheless, the ongoing study suggests that any known side effects are not severe enough to halt testing.

Prospective participants should consult the study team to understand the potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Anti-tumor B is unique because it delivers a high dose of 1,200 mg three times a day, which is different from conventional cancer treatments that typically rely on chemotherapy or radiation therapy. Researchers are excited about Anti-tumor B because it potentially targets cancer cells more precisely with fewer side effects. Unlike traditional treatments that can damage healthy cells, Anti-tumor B's approach may minimize harm to the body's normal tissues.

What evidence suggests that Anti-tumor B might be an effective treatment for cancer?

Research shows that Anti-tumor B (ATB), a combination of six Chinese herbs, may help slow cancer growth. In studies with mice, ATB reduced the number of tumors by about 40% and made tumors 70% smaller. This suggests it might help fight cancer by lessening the tumor load. The herbs in ATB are known for reducing heat, toxins, and swelling, which might explain their effect on tumors. These early results offer a hopeful look at ATB's potential as a cancer treatment. Participants in this trial will receive ATB to further evaluate its effectiveness in humans. ^{1 2 4 6 7}

Who Is on the Research Team?

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take Anti-tumor B, 1,200 mg three times a day, until the evening prior to surgery

1-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

(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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15021904/

Cancer chemopreventive activity of a mixture of Chinese ... Treatment with ATB resulted in an approximately 40% decrease in tumor multiplicity and a 70% decrease in tumor load in both wild-type mice and in mice with a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04230057

Pharmacokinetics Study of Antitumor B in Healthy Volunteers Antitumor B (ATB), also known as Zeng Sheng Ping, is a Chinese herbal mixture composed of six plants: Sophora tonkinensis, Polygonum bistorta, ...

3. withpower.com withpower.com/trial/early-phase-1-cell-transformation-neoplastic-8-2021-e747a

Anti-tumor B for Cancer · Info for Participants 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378874119351815

Chemopreventive effect of modified zengshengping on oral ... The Chinese herbal mixture ZengShengPing (ZSP) is usually called anti-tumor B because it reduces heat, toxins, and swell, promotes blood ...

5. mdpi.com mdpi.com/1422-0067/18/3/656

Understanding the Effectiveness of Natural Compound ... Anti-tumor B (ATB), known as Zeng Sheng Ping, is also an herbal medicine which is formulated from six different medicinal plants, and its main constituents are ...

6. reporter.nih.gov reporter.nih.gov/search/ojQKLJSooEWRTQ6XaDZ6yQ/project-details/10516360

Inhibition of Oral Tumorigenesis by Antitumor B Previously, clinical studies have shown significant chemopreventive efficacy of ATB against human esophageal squamous cell carcinomas and oral cancers. In a ...

7. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA205633

Funded Grants | Division of Cancer Prevention Antitumor B (ATB), also known as Zeng Sheng Ping, is a tablet made according to modern GMP standards. It contains the extracts of following ...