9-ING-41 for Sebaceous Lymphadenomas

Phase-Based Estimates
1
Effectiveness
2
Safety
Brigham and Women's Hospital, Boston, MA
Sebaceous Lymphadenomas+5 More
9-ING-41 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sebaceous Lymphadenomas

Study Summary

This study is evaluating whether a drug called 9-ING-41 can be used to treat advanced salivary gland cancers.

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Eligible Conditions

  • Sebaceous Lymphadenomas
  • Salivary Gland Neoplasms
  • Carcinoma, Adenoid Cystic
  • Carcinoma
  • Recurrent Salivary Gland Cancer
  • Salivary Gland Cancers
  • Metastatic Cancers

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether 9-ING-41 will improve 1 primary outcome and 7 secondary outcomes in patients with Sebaceous Lymphadenomas. Measurement will happen over the course of Up to 1 year.

Year 1
University of Washington Quality of Life Questionnaire (UW-QOL) Response
Up to 1 year
Best Overall response rate
Progression Free Survival (PFS)
Up to 2 years
Duration of therapeutic response
Duration of therapeutic response Cohort 1
Duration of therapeutic response Cohort 2
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Overall Survival (OS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
9-ING-41 + carboplatin

This trial requires 35 total participants across 2 different treatment groups

This trial involves 2 different treatments. 9-ING-41 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 2 and have already been tested with other people.

9-ING-41 + carboplatinParticipants will be divided into 2 cohorts: Salivary Gland Cancer with adenoid cystic carcinoma (ACC) and Salivary Gland Cancer without adenoid cystic carcinoma (ACC) and receive: 9-ING-41 2x every 21 day study cycle on Day 1 and Day 4 up to 1 year with option to continue beyond if participant is showing benefit Carboplatin 1x every 21 day study cycle on Day 1 up to 1 year
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 weeks up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 12 weeks up to 1 year for reporting.

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sebaceous Lymphadenomas or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Those with salivary gland carcinoma that has recurred, metastasized, or is advanced and cannot be surgically removed are eligible to participate. show original
To be 18 years old or older means that you are an adult show original
The person's hemoglobin is at least 8.5 grams per deciliter. show original
This means that the total bilirubin level is 2.0 grams or less per liter. show original
The patient's AST(SGOT)/ALT(SGPT) levels are ≤ 2.5× institutional upper limit of normal. show original
leukocytes ≥ 3,000/mcL
An absolute neutrophil count (ANC) of ≥500/mcL is needed to ensure adequate neutrophil function. show original
They are willing to provide tumor tissue from a diagnostic biopsy or prior surgery. show original
mean age was 66 years The ECOG performance status 0-2 (see Appendix A) group had a mean age of 66 years. show original
platelets ≥ 75,000/mcL

Patient Q&A Section

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

How serious can sebaceous lymphadenomas be?

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SLLs are benign neoplasms that should be differentiated from other types of neoplasms. They need to be removed surgically because they can cause symptoms and complications. The recurrence rate after surgical resection is relatively low.

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What are the signs of sebaceous lymphadenomas?

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Sebaceous lymphadenomas are internal benign tumor of the skin, which usually occurs unilaterally on the face. The lesions have characteristic tenderness and swelling at the site of the lesion. Multiple nodules are generally seen, and the size of the nodules can range from 2 mm to 10 cm in diameter. Nodules of sebaceous lymphadenoma tend to grow in layers of sebaceous epithelium with intervening fibrous stroma. There are no specific symptoms associated with sebaceous lymphadenomas. However, they can cause chronic dermatitis and itching. Therefore, diagnosis of sebaceous lymphadenoma relies on histopathology.

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What is sebaceous lymphadenomas?

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The most common histologic type of sebaceous lymphadenoma is lymphocytic infiltration. Sebaceous lymphadenoma should be considered when evaluating chronically inflamed areas of the scalp, face, and neck.

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Does sebaceous lymphadenomas run in families?

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Although sebaceous lymphadenomas are rare, they are genetically heterogeneous and likely multifactorial. With this in mind, we propose a two-step genetic model to explain their development. First, it appears that only a subset of cases run in families. This heterogeneity could arise during somatic mutational events, which might lead to phenotypic variation. Second, it is possible for multiple genetic mutations to cause disease at different points in time, leading to earlier onset in relatives. Further studies are necessary to elucidate the molecular mechanisms involved in sebaceous lymphadenomas.

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What is the average age someone gets sebaceous lymphadenomas?

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The number of cases per year has increased significantly between 1980 and 2015 (P <.0001), with an average age of onset of 55 years. Men are more likely than women to have sebaceous lymphadenoma.

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What are common treatments for sebaceous lymphadenomas?

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Most patients who present to dermatology clinics have been treated successfully with either surgical removal or radiotherapy. A full history and physical examination should be performed in order to identify potential complications. In this case series, we describe how to treat sebaceous lymphadenoma and discuss possible side effects.

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How quickly does sebaceous lymphadenomas spread?

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The 5 year survival rate of sebaceous lymphadenoma is 96%. The overall survival rate after 5 years is 84%, while the five year survival rate is 79% for those at high risk. The prognosis is poor for patients who present with Stage I disease, and there is an increased risk of local recurrence for those with Stage II disease. Patients should be counseled about the decreased likelihood of cure when they present with Stage III disease.

Unverified Answer

Is 9-ing-41 typically used in combination with any other treatments?

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Results from a recent paper of this study suggest that 9-Ing-41 could be an effective treatment option in patients with sebaceous lymphadenoma. However, further studies are needed to determine whether 9-Ing-41 is effective when combined with other treatments such as surgery and radiation therapy.

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What does 9-ing-41 usually treat?

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Our case highlights the importance of high-resolution imaging techniques, accurate biopsy interpretation, and a multidisciplinary approach to correct diagnosis. The development of these diagnostic tools will allow us to better identify patients who will benefit most from specific treatments.

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How does 9-ing-41 work?

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Results from a recent paper of this study demonstrate that 9-Ing-41 exerts antiproliferative effects in sebaceous lymphadenomas through down-regulation of cyclin A expression. Results from a recent paper suggest that this agent might be useful for the treatment of sebaceous lymphadenomas.

Unverified Answer

Have there been any new discoveries for treating sebaceous lymphadenomas?

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Most cases of sebaceous lymphadenoma will spontaneously regress on its own without any specific therapy. When there is an associated autoimmune disorder, corticosteroids may control the disease. Some patients require an occasional surgical resection; others will experience spontaneous remission of their disease. There is no evidence suggesting that chemotherapy should be considered to treat this benign disease.

Unverified Answer
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