What side effects are associated with this type of intervention?

Common treatments for salivary gland cancer include chemotherapy and targeted therapies. Carboplatin, a chemotherapy agent, can cause side effects such as nausea, vomiting, fatigue, decreased blood cell counts, and increased risk of infection. GSK-3β inhibitors like 9-ING-41, while still under investigation, may have side effects including gastrointestinal disturbances, fatigue, and potential impacts on blood glucose levels. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for salivary gland cancer involving GSK-3β inhibitors like 9-ING-41. However, carboplatin, a chemotherapy agent, is commonly used in various cancers, including head and neck cancers, which can be similar in treatment approach to salivary gland cancers. Other treatments for salivary gland cancer often include surgery, radiation therapy, and other chemotherapy agents. Targeted therapies and novel agents are also being explored in clinical trials to improve outcomes for patients with advanced salivary gland cancers.

What other types of research exist?

Promising novel alternatives for Salivary Gland Cancer patients could include PI3K inhibitors like GSK2636771, which has shown some activity in other cancers, and mTOR inhibitors such as temsirolimus, which has demonstrated potential in endometrial cancer. Additionally, CDK inhibitors like palbociclib and dinaciclib, which have shown cytotoxic activity in head and neck cancers, may also be considered.

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GSK-3β inhibitor

9-ING-41 + Carboplatin for Salivary Gland Cancer

Phase 2

Waitlist Available

Led By Glenn J Hanna, MD

Research Sponsored by Glenn J. Hanna

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Organ and marrow function within specified limits

Age 18 years or older

Must not have

Known additional malignancy that is progressing or requires active treatment

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks up to 1 year

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug called 9-ING-41 for patients with advanced salivary gland cancers that don't respond to usual treatments. The new drug aims to slow down the cancer by blocking a specific function that helps cancer cells grow.

Who is the study for?

Adults with advanced salivary gland cancer, including adenoid cystic carcinoma, who have not responded to previous treatments or whose disease has returned. They must be in relatively good health with proper organ and bone marrow function, able to provide tissue samples, and willing to use effective contraception.

What is being tested?

The trial is testing the effectiveness of a new drug called 9-ING-41 (a GSK-3β inhibitor) when given through IV alongside Carboplatin chemotherapy. The goal is to see if this combination can help treat advanced salivary gland cancers more effectively.

What are the potential side effects?

Potential side effects may include reactions related to the infusion process, impact on blood cells leading to increased infection risk or bleeding problems, kidney or liver function changes, fatigue, and other common chemotherapy-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ and bone marrow functions are within normal ranges.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My salivary gland cancer has returned, spread, or cannot be surgically removed.

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I am willing to provide samples from my previous cancer surgery or biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or needs treatment.

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I have cancer that has spread to my brain or surrounding membranes.

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My cancer is affecting my spinal cord.

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I am on blood thinners that need regular INR checks.

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I do not have any uncontrolled illnesses.

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I am not currently receiving any other cancer treatments or experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall response rate

Secondary study objectives

Duration of therapeutic response

Duration of therapeutic response Cohort 1

Duration of therapeutic response Cohort 2

+4 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 9-ING-41 + carboplatinExperimental Treatment2 Interventions

Participants 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

9-ING-41

Not yet FDA approved

Carboplatin

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The treatment of Salivary Gland Cancer often involves chemotherapy and targeted therapies. Carboplatin, a platinum-based chemotherapy, works by causing DNA damage that leads to cancer cell death. However, its effectiveness can be limited by drug resistance mechanisms, such as the expulsion of the drug from cancer cells via copper transporters like ATP7B. The GSK-3β inhibitor 9-ING-41, on the other hand, targets the glycogen synthase kinase-3 beta (GSK-3β) pathway, which is involved in various cellular processes including cell proliferation and survival. By inhibiting GSK-3β, 9-ING-41 can potentially enhance the effectiveness of chemotherapy and overcome resistance. This combination is particularly relevant for Salivary Gland Cancer patients as it offers a multi-faceted approach to targeting cancer cells, potentially improving treatment outcomes.

Stress hormone norepinephrine incites resistance of oral cancer cells to chemotherapy.Ammonium tetrathiomolybdate enhances the antitumor effect of cisplatin via the suppression of ATPase copper transporting beta in head and neck squamous cell carcinoma.Single-Cell RNA Sequencing of Hematopoietic Stem and Progenitor Cells Treated with Gemcitabine and Carboplatin.