Trichostatin A for Blood Cancer

Recruiting at 9 trial locations

Overseen By Vanda Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanda Pharmaceuticals

Must not be taking: Anti-cancer therapy

Disqualifiers: GVHD, Cardiac issues, Severe conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called trichostatin A, a type of drug, for individuals with certain blood cancers that have returned or not responded to standard treatments. The main goal is to assess the drug's safety and tolerability. It targets those who have tried other therapies without success and have a measurable or observable type of blood cancer. Ideal participants are adults who have exhausted other treatment options and do not currently experience active complications from past treatments, such as a stem cell transplant. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any other anti-cancer therapies, but bisphosphonates are allowed. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that trichostatin A is likely to be safe for humans?

Research has shown that trichostatin A, a substance that influences cell growth, has undergone testing in humans. Studies found it can stop cancer cells from growing and even cause them to die. However, these effects were primarily observed in lab experiments, not in humans.

The current trial is in an early stage, focusing on determining the safety of trichostatin A for humans. Early-stage trials typically begin with low doses to monitor the body's reaction, gradually increasing the dose if it appears safe. Success in this trial could lead to further studies with more participants to better understand its safety and effectiveness.

In summary, lab evidence suggests trichostatin A can fight cancer cells, but more research is needed to confirm its safety in people with blood cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and targeted therapies used for blood cancer, Trichostatin A is unique because it functions as a histone deacetylase (HDAC) inhibitor. Most treatments work by killing rapidly dividing cells, but Trichostatin A targets the epigenetic regulation of cancer cells, potentially reactivating tumor suppressor genes. Researchers are excited about this approach because it offers a novel way to disrupt cancer cell growth and survival, opening new avenues for treating resistant or aggressive blood cancers.

What evidence suggests that trichostatin A might be an effective treatment for blood cancer?

Research has shown that trichostatin A (TSA), the investigational treatment in this trial, may help treat certain cancers. TSA blocks a process that cancer cells use to grow. Studies have found that TSA can hinder cancer cells from spreading by reducing their ability to move and invade other areas. In some research, TSA also broke down proteins that cancer cells need to survive. While more information is needed, these early findings suggest TSA could be effective against blood cancers. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with blood cancers like leukemia or lymphoma that have come back or didn't respond to standard treatments. Participants should still have signs of cancer that can be measured, be able to do daily activities (ECOG ≤ 2), and use birth control.

Inclusion Criteria

Contraceptives or other approved avoidance of pregnancy measures

I am 18 years old or older.

My blood cancer has not responded to standard treatments and no other options are available.

Exclusion Criteria

I had a stem cell transplant and am dealing with GVHD.

I am not on any cancer treatment except for bisphosphonates.

I have not had major surgery in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trichostatin A to assess safety and tolerability

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trichostatin A

Trial Overview The study is testing Trichostatin A's safety in patients whose blood cancers haven't improved after treatment. It aims to see how well these individuals tolerate the drug.

How Is the Trial Designed?

Group I: Trichostatin A Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03838926

NCT03838926 | Tolerability Study of Trichostatin A In ... The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6118243/

Trichostatin A promotes GLI1 degradation and P21 ... Trichostatin A (TSA), a histone deacetylase inhibitor, exhibits effective antitumor effects in various cancers. However, the effects and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000649712409904X

Acetylation and Transcriptomic Activity of Vtr-297 We have conducted a high throughput screen to delineate early acetylation effects related to exposure to Trichostatin A (TSA) on patient-derived, clinical time ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9612318/

Pharmacological Properties of Trichostatin A, Focusing on ... This compound suppressed the invasion and migration and reduced the radio resistance in many cancer cell lines in a time- and dose-dependent manner.

5. ashpublications.org ashpublications.org/blood/article/101/9/3451/105802/Two-histone-deacetylase-inhibitors-trichostatin-A

Two histone deacetylase inhibitors, trichostatin A and sodium ... The effect of 2 HDAC inhibitors, trichostatin A (TSA) and sodium butyrate (NaB), on osteoclastogenesis was investigated using rat and mouse bone marrow ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03838926

NCT03838926 | Tolerability Study of Trichostatin A In ... The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

7. stemcell.com stemcell.com/products/trichostatin-a.html

Trichostatin A Trichostatin A is a potent inhibitor of Histone Deacetylase (HDAC) that prevents removal of acetyl groups from lysine residues on histone tails.

8. asco.org asco.org/abstracts-presentations/ABSTRACT344089

Trichostatin A sensitivity signature across hematological ... These anticancer agents affect epigenetic and non-epigenetic gene expression resulting in cell cycle arrest of cancer cells. Furthermore HDACi can enhance its ...