What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma (STS) include chemotherapy agents like doxorubicin, dacarbazine, and eribulin, which are associated with side effects such as neutropenia, alopecia, nausea, vomiting, and cardiotoxicity. Eribulin, in particular, can cause higher rates of neutropenia, pyrexia, peripheral sensory neuropathy, and alopecia. Pegfilgrastim, used to reduce neutropenia, can cause bone pain, fatigue, and injection site reactions. Combining these treatments, as in the trial with camsirubicin and pegfilgrastim, aims to manage neutropenia but may still present a range of these side effects.

What prior FDA approvals exist?

The FDA has approved several chemotherapy agents for the treatment of Soft Tissue Sarcoma (STS). Doxorubicin, often considered the standard first-line treatment, is an anthracycline similar to camsirubicin. Ifosfamide is another commonly used agent, frequently combined with doxorubicin for enhanced efficacy. To manage chemotherapy-induced neutropenia, the FDA has approved granulocyte colony-stimulating factors (G-CSFs) like pegfilgrastim, which is used prophylactically to reduce the risk of infection. These treatments form the backbone of current STS management, aligning closely with the investigational approach of combining camsirubicin with pegfilgrastim.

What other types of research exist?

Promising novel alternatives for Soft Tissue Sarcoma patients include: <ol> <li>Regorafenib: Demonstrated safety and efficacy in advanced STS.</li> <li></li> </ol> Cabozantinib: Limited activity but potential in investigational settings. 3. Sorafenib: Shown activity in metastatic or recurrent sarcomas. 4. Lenvatinib: Limited activity in combination with etoposide and ifosfamide. 5. Eribulin: Improved overall survival in liposarcoma patients. 6. Nab-sirolimus: Suggested for advanced unresectable or metastatic malignant neoplasm with perivascular epithelioid cell differentiation (PEComa).

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Anti-tumor antibiotic

Camsirubicin for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Research Sponsored by Monopar Therapeutics

Eligibility Criteria Checklist

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

Must have

Age ≥18 years.

Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Must not have

The participant has a known, uncontrolled active fungal, uncontrolled bacterial, or uncontrolled viral infection including human immunodeficiency virus (HIV) or viral hepatitis (B or C).

The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks after first injection

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests camsirubicin, a new chemotherapy drug, with a supportive medication to prevent low white blood cell counts. It targets patients with advanced soft tissue sarcomas who need new treatment options. Camsirubicin kills cancer cells, and the supportive medication helps the body recover from chemotherapy by increasing the survival of white blood cells.

Who is the study for?

Adults with advanced soft tissue sarcomas who haven't had anthracycline treatment, are in good physical condition (ECOG 0-1), and have proper organ function. They must not be pregnant or breastfeeding, agree to use contraception, and have a life expectancy of at least 3 months. Excluded are those intolerant to pegfilgrastim or with certain heart conditions, brain metastasis, active infections like HIV/hepatitis, or other recent cancers.

What is being tested?

The trial is testing the safety of camsirubicin combined with pegfilgrastim for treating advanced soft tissue sarcomas. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and will also assess how well it works through various health measures including quality of life.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever or bone pain due to pegfilgrastim; typical chemotherapy-related issues like nausea, fatigue, hair loss; and potential heart problems from camsirubicin.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have never been treated with anthracyclines.

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My cancer is a type of advanced sarcoma that cannot be removed by surgery or cured with radiation.

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I haven't had chemotherapy for advanced sarcoma and can receive anthracycline.

Exclusion Criteria

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

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I do not have any uncontrolled infections like HIV or hepatitis.

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I have not had a heart attack or any heart procedures in the last 6 months.

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I have been diagnosed with a specific type of sarcoma.

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I have serious heart issues, including heart failure or irregular heartbeat.

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I am not pregnant or breastfeeding.

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I have been treated with specific chemotherapy drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks after first injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks after first injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks after first injection for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recommended Phase 2 Dose (RP2D) Camsirubicin HCl for Injection

To determine Maximum Tolerated Dose (MTD)

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety]

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Camsirubicin + pegfilgrastimExperimental Treatment1 Intervention

Camsirubicin phase 1b dose escalating to determine MTD

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

Chemotherapy agents such as doxorubicin and camsirubicin work by intercalating DNA strands, which inhibits cancer cell replication and induces apoptosis. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF), is used to reduce chemotherapy-induced neutropenia by stimulating white blood cell production. This combination is important for Soft Tissue Sarcoma patients as it enables the administration of higher chemotherapy doses safely, potentially enhancing treatment effectiveness while managing side effects.

IEVM chemotherapy with rhGM-CSF support for aggressive non-Hodgkin's lymphomas: a pilot study.Doxorubicin-Loaded Polymeric Meshes Prevent Local Recurrence after Sarcoma Resection While Avoiding Cardiotoxicity.Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study.