CLINICAL TRIAL

AL3818 for Sarcoma, Alveolar Soft Part

Recruiting · 18+ · All Sexes · Palermo, Italy

This study is evaluating whether a drug may help treat sarcoma.

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About the trial for Sarcoma, Alveolar Soft Part

Eligible Conditions
Synovial Sarcoma · Sarcoma · Leiomyosarcoma · Sarcoma, Synovial · Sarcoma, Alveolar Soft Part · Alveolar Soft Part Sarcoma (ASPS) · Soft Tissue Sarcoma (STS)

Treatment Groups

This trial involves 6 different treatments. AL3818 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
AL3818
DRUG
Experimental Group 2
Dacarbazine
DRUG
Experimental Group 3
AL3818
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dacarbazine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sarcoma, Alveolar Soft Part or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment (excluding ASPS subjects who have not received prior therapy).
Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.
Male or female at least 18 years of age.
a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone). c. CLOSED Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma. d. CLOSED Indication D - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).
a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy. (New Recruitment Suspended) c. Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). d. Indication D - LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment. Patients must have received and progressed on prior therapy and have been treated any line with an anthracycline.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 3 months.
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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: Up to 48 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 48 months.
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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 AL3818 will improve 2 primary outcomes and 2 secondary outcomes in patients with Sarcoma, Alveolar Soft Part. Measurement will happen over the course of From time of randomization to the date of disease progression or death from any cause, up to 48 months.

Progression Free Survival (PFS) (LMS/SS)
FROM TIME OF RANDOMIZATION TO THE DATE OF DISEASE PROGRESSION OR DEATH FROM ANY CAUSE, UP TO 48 MONTHS
To compare PFS in subjects with LMS or SS randomized to AL3818 versus dacarbazine, defined a median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs earlier as evaluated by a blinded independent radiologic review (BICR).
Duration of Response (DOR) (ASPS)
UP TO 48 MONTHS
To determine DOR in subjects with ASPS, defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes
Objective Response Rate (ORR) (LMS/SS)
UP TO 48 MONTHS
To compare ORR in subjects with LMS or SS randomized to AL3818 versus dacarbazine, defined as percentage of subjects who achieve a Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1 as evaluated by a blinded independent radiological review (BICR).
Objective Response Rate (ORR) (ASPS)
UP TO 48 MONTHS
To determine ORR in subjects with ASPS, defined as percentage of subjects who achieve a Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1 as evaluated by a blinded independent radiological review (BICR).

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 sarcoma, alveolar soft part be cured?

The authors believe the data reported here support previous evidence for the concept that there are circumstances in which sarcoma can be cured. However, this cure may be difficult to confirm because the disease can relapse.

Anonymous Patient Answer

How many people get sarcoma, alveolar soft part a year in the United States?

A large number of people have sarcoma, alveolar soft part a year in the United States. Most patients (71%) had high grade soft tissue sarcoma and 40% had soft tissue sarcoma at the time of diagnosis, which suggests that patients with soft tissue sarcoma, specifically high grade sarcoma, are likely to be misdiagnosed at the time of diagnosis. Inadequate treatment or delayed management is one factor that contributes to the high number of deaths secondary to sarcoma, alveolar soft part a year in the United States.

Anonymous Patient Answer

What causes sarcoma, alveolar soft part?

The causes of alveolar soft part sarcomas are a more complex issue, than we suppose. In most reports about tumor morphology, we can see alveolar soft part sarcomas. Most of them occur due to radiation therapy, which is usually used for the control of local and distant neoplasms. In an attempt to eradicate the tumor cells, we can see in most cases a better prognosis and a better patient's outcome.

Anonymous Patient Answer

What are the signs of sarcoma, alveolar soft part?

We have not been able to identify the signs specific to STS/ASPS. Many general signs of cancer are present, but it remains a long time to diagnosis.

Anonymous Patient Answer

What is sarcoma, alveolar soft part?

Sarcoma, alveolar soft part is a type of cancer that mostly starts within the limbs, or soft tissues around them. The American Cancer Society estimates 5,000 new sarcoma cases in the United States, which accounts for nearly one third of all cancer cases that are diagnosed in that age group. It can be difficult to diagnose, as tumors in other areas of the body may be present concurrently. The disease is highly aggressive, with a low survival rate.

Anonymous Patient Answer

What are common treatments for sarcoma, alveolar soft part?

Bullet lesions are almost always resected, depending on size and extension of tumours. However, in most cases, there is no residual tumour on histologic examination, provided that the patient survives the initial course of chemotherapy.

Anonymous Patient Answer

How quickly does sarcoma, alveolar soft part spread?

The survival time between diagnosis and surgery has increased from a median time of 37 days to an average of 52 days. This is more than three and a halffold longer than reported by studies of the early 1970s. This increase in survival time has coincided with a decrease in mortality in sarcoma from a 10-year survival rate of 49% in 1970 to 37% in 2010. This decrease is in the range of what is commonly called improved survival.

Anonymous Patient Answer

Have there been any new discoveries for treating sarcoma, alveolar soft part?

There were no studies of new treatments for [soft tissue sarcoma](https://www.withpower.com/clinical-trials/soft-tissue-sarcoma) or alveolar soft part sarcoma in either systematic review. Although there may be new treatment options for sarcoma, alveolar soft part sarcoma, and other sarcomas, more research and clinical trials are needed.

Anonymous Patient Answer

What is the latest research for sarcoma, alveolar soft part?

For sarcoma, metastases in bone may occur in patients with advanced, bulky disease, but local control is very poor. Advanced lymphocytic sarcoma may regress on chemotherapy. For patients with localized sarcoma, local limb amputation should not be routinely prescribed, due to the risk of early malignant transformation (metaplastic changes) in high-grade tumors. If local control with limb amputation is used, the ultimate 5-year survival rate can be around 5-10%. The 5-year survival rate for patients with advanced tumors, no residual disease, and metastases in bones, is around 35-40% for limb amputation and 60% for limb conservation. These patients can benefit from new therapy.

Anonymous Patient Answer

What are the chances of developing sarcoma, alveolar soft part?

The risk and incidence rates are low for development ALPS, but a small number of cases will have sarcomas. Patients with sarcomas in the extremities have better outcomes, while patients with sarcomas elsewhere do worse. Patients who develop an ALPS may have longer terms survival after diagnosis if treated with R-CHOP, CHOP with autologous stem cell transplant, or CHOP with ASCT.

Anonymous Patient Answer

What is the average age someone gets sarcoma, alveolar soft part?

The average age at diagnosis of sarcoma and ASPS in this study was 32.3 years for women and 34.6 for men. These ages are higher than that reported in the literature. The majority of sarcomas and ASPS occur in the 30 years of age and above age range. This age group in the United States is predominantly female. The average age at diagnosis for ASPS was lower in this study at 27 years, although this result could be skewed by the small sample size.

Anonymous Patient Answer

What are the common side effects of al3818?

Al3818 is known to be efficacious in the treatment of the most common form of skin cancer, alveolar soft part sarcoma (ASPS). However, it is not expected to have any major side effects outside of those that occur in the majority of patients with ASPS. Al3818 should not be used by patients who have a history of hypersensitive reactions to al3818 or those who are allergic to any of the inactive ingredients. Al3818 should not be given to children under three years old, who should be taken to a medical professional immediately after using al3818. If these precautions cannot be heeded, medical advice should be sought immediately.

Anonymous Patient Answer
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