What is the mechanism of action of this treatment?

Common treatments for Soft Tissue Sarcoma (STS) include chemotherapeutic agents like doxorubicin and its derivatives, which work by intercalating into DNA, thereby disrupting the replication and transcription processes essential for cell division. L-Annamycin, a lipophilic anthracycline analog, also targets DNA replication but with reduced cardiotoxicity compared to traditional anthracyclines. These mechanisms are crucial for STS patients as they directly inhibit tumor growth and proliferation. Additionally, surgical resection and radiation therapy are often employed to remove or shrink tumors, especially in cases where chemotherapy alone is insufficient. Understanding these mechanisms helps in tailoring treatment plans that maximize efficacy while minimizing adverse effects.

What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma (STS) that are similar to L-Annamycin, such as doxorubicin and its liposomal formulations, often have significant side effects. Doxorubicin is known for its cardiotoxicity, which can lead to congestive heart failure, and other side effects like alopecia, nausea, and vomiting. Liposomal doxorubicin formulations tend to have reduced cardiotoxicity but can still cause hematological toxicity, palmar-plantar erythrodysthesias (PPE), and mucosal inflammation. Gemcitabine and docetaxel, often used in combination, can lead to increased toxicity, including edema and constitutional symptoms, which may result in treatment discontinuation.

What prior FDA approvals exist?

Several chemotherapeutic agents have been approved by the FDA for the treatment of Soft Tissue Sarcoma (STS). Doxorubicin, an anthracycline antibiotic, is a cornerstone in the treatment of STS due to its ability to interfere with DNA replication and cell division. Liposomal formulations of doxorubicin, such as Doxil, have also been explored to reduce toxicity. Another notable agent is eribulin, which has shown efficacy in patients with advanced liposarcoma and leiomyosarcoma. Additionally, pazopanib, a tyrosine kinase inhibitor, has been approved for the treatment of advanced STS, excluding liposarcoma, due to its antiangiogenic properties. These treatments highlight the ongoing efforts to improve outcomes for patients with STS through various mechanisms of action.

What other types of research exist?

Promising novel alternatives to L-Annamycin for Soft Tissue Sarcoma patients include: 1) Gemcitabine plus Docetaxel, which has shown superiority over Gemcitabine alone in metastatic STS, particularly in undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma. 2) Aclacinomycin-A, which has demonstrated therapeutic synergism when combined with Cyclophosphamide or Vincristine in preclinical models. 3) Bleomycin A6, which has shown potent antitumor activity against colon cancer xenografts and may be useful in human cancer chemotherapy.

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Anti-tumor antibiotic

Liposomal Annamycin for Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Moleculin Biotech, Inc.

Eligibility Criteria Checklist

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

Must have

At least 2 weeks must have passed following treatment for subject's disease with chemotherapy, investigational therapy, targeted agents, biological agents, immune modulators, or radiotherapy. Any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than 4 weeks after completing therapy (except alopecia and polyneuropathy).

The subject must have the following adequate laboratory results within 72 hours of starting protocol therapy: Absolute neutrophil count ≥ 1500/mL, Platelet count ≥100,000/mL, Hemoglobin ≥ 8.0 g/dL, Adequate renal function, Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome), Aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 × ULN (≤ 5 x ULN in subjects with liver metastases).

Must not have

The subject has any of the following cardiotoxicities: Left ventricular ejection fraction (LVEF) <50%, Valvular heart disease, Severe hypertension not controlled by medical therapy, New York Heart Association classification of 3 or 4, Recent (≤ 6 months) myocardial infarction, Unstable angina, Symptomatic congestive heart failure, Baseline QT/QTc interval >480 msec, History of additional risk factors for torsade des pointes, Use of concomitant medications that significantly prolong the QT/QTc interval.

The subject has a known allergy to study drug, L-Annamycin, or excipients.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 ( each cycle is 21 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing L-Annamycin, a medication aimed at treating patients with soft tissue sarcoma that has spread to the lungs. The study will determine how much of the drug can be safely given and if it effectively kills cancer cells.

Who is the study for?

This trial is for adults with soft-tissue sarcomas that have spread to the lungs and are not candidates for surgery. Participants must have a life expectancy over 3 months, measurable lung disease, adequate blood counts and organ function, and no severe heart conditions or uncontrolled illnesses. They should be past certain treatments with resolved side effects (except hair loss and neuropathy) and agree to use contraception.

What is being tested?

The study tests Liposomal Annamycin (L-Annamycin), an experimental drug for treating lung metastases from soft-tissue sarcoma. Phase 1b determines the safest dose while Phase 2 assesses its effectiveness as a single treatment agent in multiple centers.

What are the potential side effects?

Potential side effects of L-Annamycin may include typical chemotherapy-related issues such as fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, liver toxicity, and possibly heart-related complications.

Eligibility Criteria

Inclusion Criteria

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

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It's been over 2 weeks since my last cancer treatment, and any side effects are mild or gone.

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Your recent blood tests show normal levels for white blood cells, platelets, and hemoglobin. Your kidneys and liver are working well, and your bilirubin levels are within a certain range.

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My lung cancer has spread, and surgery is not an option, but I can receive chemotherapy.

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I am 18 years old or older.

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My diagnosis of soft tissue sarcoma is confirmed by a pathology report.

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

Exclusion Criteria

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

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I have heart issues such as low heart pump function, severe uncontrolled high blood pressure, recent heart attack, or conditions that affect my heart's rhythm.

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I am allergic to the study drug or its components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 ( each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 ( each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 ( each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Limiting Toxicity

Secondary study objectives

Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin

Efficacy of L-Annamycin

Awards & Highlights

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: Liposomal Annamycin (L-Annamycin)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal Annamycin (L-Annamycin)

2021

Completed Phase 2

~40

0 / 8Eligibility 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

Common treatments for Soft Tissue Sarcoma (STS) include chemotherapeutic agents like doxorubicin and its derivatives, which work by intercalating into DNA, thereby disrupting the replication and transcription processes essential for cell division. L-Annamycin, a lipophilic anthracycline analog, also targets DNA replication but with reduced cardiotoxicity compared to traditional anthracyclines. These mechanisms are crucial for STS patients as they directly inhibit tumor growth and proliferation. Additionally, surgical resection and radiation therapy are often employed to remove or shrink tumors, especially in cases where chemotherapy alone is insufficient. Understanding these mechanisms helps in tailoring treatment plans that maximize efficacy while minimizing adverse effects.

[Effect of the plan of using antitumor preparations on their efficacy in sarcoma 37].A phase II evaluation of methyl CCNU and actinomycin D in the treatment of advanced sarcomas in adults.Design and tumor targeting of anthracyclines able to overcome multidrug resistance: a double-advantage approach.