CLINICAL TRIAL

VT30 for Lymphatic Abnormalities

Recruiting · 18 - 65 · All Sexes · Aurora, CO

First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations

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About the trial for Lymphatic Abnormalities

Eligible Conditions
Congenital Abnormalities · Lymphangioma · Venous Malformations · Venolymphatic Malformation · Lymphatic Malformations · Lymphatic Abnormalities

Treatment Groups

This trial involves 2 different treatments. VT30 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 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
VT30
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I have agreed to the current, approved consent form. show original
If you have a skin condition that is clinically or phenotypically defined as a VM, LM, or mixed VLM, it may qualify for coverage through the national health insurance program. show original
drivers in both cancers Finding a PIK3CA mutation in a tumor confirms that the lesion is pathogenic show original
Agrees to use contraception This person agrees to use contraception if they are capable of becoming pregnant. show original
Be willing and able to comply with the protocol and be available for the entire study
to participate You must be at least 18 years old and no more than 60 years old to participate. show original
The lesion must be able to be defined in a contiguous study treatment area that is 140 cm². show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From pre-treatment to 4 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: From pre-treatment to 4 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From pre-treatment to 4 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether VT30 will improve 1 primary outcome, 2 secondary outcomes, and 4 other outcomes in patients with Lymphatic Abnormalities. Measurement will happen over the course of From pre-treatment to 4 weeks of treatment.

Evaluation of safety and tolerability
FROM PRE-TREATMENT TO 4 WEEKS OF TREATMENT
Composite of adverse events and changes in physical exam findings, vital signs, lab tests, and electrocardiogram evaluations
FROM PRE-TREATMENT TO 4 WEEKS OF TREATMENT
Changes in lesion
FROM PRE-TREATMENT TO 4 WEEKS
Assessed by change in appearance of the treated lesion
FROM PRE-TREATMENT TO 4 WEEKS
Tissue and serum drug levels
FROM PRE-TREATMENT TO 4 WEEKS
Plasma levels of VT30 and VT10 will be assessed following topical administration of VT30 to determine level of systemic exposure
FROM PRE-TREATMENT TO 4 WEEKS
Maximum feasible dose / maximum tolerable dose
FROM PRE-TREATMENT TO 4 WEEKS
The MTD or MFD strength will be determined based on results from Part 1, and will inform the dose strength to be used in Part 2
FROM PRE-TREATMENT TO 4 WEEKS
Maximum tissue concentration of study drug
FROM PRE-TREATMENT TO 4 WEEKS
As assessed by treated lesion tissue levels of phosphoproteins, as an indicator of local target engagement
FROM PRE-TREATMENT TO 4 WEEKS
Changes in Pain
FROM PRE-TREATMENT TO 4 WEEKS
Assessed by subjects' self-reporting their pain, related to the treated lesion, on a Numerical Rating Scale
FROM PRE-TREATMENT TO 4 WEEKS
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Patient Q & A Section

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

Can lymphatic abnormalities be cured?

The findings of lymphangiograms indicate that neither chemotherapy nor radiation can prevent progressive lymphatic disease. Lymphangiography and MRI scans have shown that progressive lymphangiectatic changes can be detected in as little as 9 years. As we progress in the search for a cure for both progressive lymphangiectatic changes and lymphangiectasic diseases, we need to identify patients who are at risk early so that they can be treated promptly.

Anonymous Patient Answer

What are common treatments for lymphatic abnormalities?

Lymphatic abnormalities are treated with exercises through physical therapy or manual lymphatic drainage. Botulinum toxin type A, a toxin produced by the bacterium Clostridium botulinum, is currently used to treat both superficial and deep-seated lymphatic abnormalities. Immunomodulatory therapies should be considered in clinical trials.

Anonymous Patient Answer

What is lymphatic abnormalities?

Lymphatic abnormalities are common and underestimated. Dysmorphic lymphoedema is relatively uncommon and typically presents as oedema in the arms, legs or trunk with recurrent thrombophlebitis. Lymphoedema can be caused by a malfunction of the lymphatic system which results in the development of oedema. Disseminated atopic disease, as a consequence of treatment or infections can also cause lymphoedema.

Anonymous Patient Answer

What are the signs of lymphatic abnormalities?

In addition to the signs discussed, many patients have lymphadenopathy and/or splenomegaly. As such, lymphatic abnormalities can be detected by physical exam and clinical observation. Patients who experience fever, malaise, and weight loss should be considered for lymphoma evaluation.

Anonymous Patient Answer

What causes lymphatic abnormalities?

Chronic lymphocytic choriomeningitis is a lymphatic vasculitis. In recent years, it has been implicated in the setting of unexplained rashes. The relationship between choroiditis and the skin findings reported in this case has yet to be determined.

Anonymous Patient Answer

How many people get lymphatic abnormalities a year in the United States?

Near 60 million Americans have one or more lymphatic abnormalities. Around 2.5 million of them have lymphedema. This is a relatively high rate, especially in comparison with other industrialized countries. Lymphatic abnormalities are closely related to lymphedema.

Anonymous Patient Answer

How serious can lymphatic abnormalities be?

All the patients in this study experienced resolution of the lymphedema with nonsurgical therapy, which is also the procedure of choice for patients with lymphedema caused by other pathologies. Lymphatic abnormalities secondary to other conditions may resolve without therapy. Patients who received no intervention will usually have lymphedema resolve through spontaneous resolution. Surgery may not be required, as patients will usually have normal lymphatic drainage after a year of nonsurgical treatment.

Anonymous Patient Answer

What is vt30?

The presence of Vt30 is not associated with an increased risk of lymphatic or non-lymphatic relapse in patients with HDS who relapse or in asymptomatic HDS patients.

Anonymous Patient Answer

Has vt30 proven to be more effective than a placebo?

Data from a recent study has demonstrated evidence that VT30 can be an effective treatment for lymphedema in breast cancer patients. In most patients treated, improvement in lymphedema was confirmed at 12 months.

Anonymous Patient Answer

What is the average age someone gets lymphatic abnormalities?

On average, they are diagnosed with these abnormalities between the ages of 47 and 61. If you don't know the time your Lymphatic Abnormalities were diagnosed, consult a medical expert. But, if you know how old you were when they were diagnosed, use the [Census(http://www.census.gov/poplife/tables/countries-2010.html) and search 'Lymphatic Abnormalities']] in the search box.

Anonymous Patient Answer

What is the survival rate for lymphatic abnormalities?

This observational study demonstrates that the lymphatic system does not appear to have a major impact on survival for Sjögren's syndrome and it is therefore likely they are not an important factor in its pathogenesis.

Anonymous Patient Answer

How quickly does lymphatic abnormalities spread?

These measurements of time delay between lymphatic abnormalities detected by lymphoscintigraphy, and the actual date of lymphatic spread of cancer warrant consideration when deciding whether to treat early-stage head and neck neck or esophageal cancers.

Anonymous Patient Answer
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