CPI-300 for Advanced Tumors

Phase-Based Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute, Nashville, TN
CPI-300 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Advanced Tumors

Study Summary

This study is evaluating whether a new drug called CPI-300 can be safely given to patients with advanced tumors.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CPI-300 will improve 1 primary outcome and 4 secondary outcomes in patients with Advanced Tumors. Measurement will happen over the course of 8 Days.

Day 28
Adverse Effect
Day 28
Clinical Benefit
28 days
Safety
8 Days
Area Under the Curve (AUC)
Maximum Plasma Concentration (Cmax)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
CPI-300

This trial requires 17 total participants across 2 different treatment groups

This trial involves 2 different treatments. CPI-300 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 1 and are in the first stage of evaluation with people.

CPI-300
Drug
Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days and additional cpi-300 treatment till disease progression or intolerability
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 28 days and additional cpi-300 treatment till disease progression or intolerability for reporting.

Closest Location

Sarah Cannon Research Institute - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a histologically or cytologically confirmed diagnosis of advanced solid tumor Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
Have an ECOG performance status of 0-1
Have adequate bone marrow reserve, liver and renal function
Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

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 many people get advanced tumors a year in the United States?

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More than 700,000 people die annually from the five most common types of cancer. Approximately half of these deaths occur among 30-year-olds and young adults.

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Has cpi-300 proven to be more effective than a placebo?

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Findings from a recent study provided no clear evidence that cisplatin plus apiculine plus capecitabine was more effective than cisplatin plus placebo plus capecitabine in patients with advanced solid tumors. There was also no proof that apiculine increased the efficacy of cisplatin-based treatment. Apiculine should not be considered as a treatment option when cisplatin-based regimens are being used in these patients.

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What causes advanced tumors?

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Results from a recent clinical trial clearly shows a relationship between advanced tumors, and the immune-regulatory mechanisms known to be implicated in the development of cancer, suggesting that tumors may be perceived in an immune-responsive fashion by the host.

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What is advanced tumors?

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The following medical conditions exist as the first manifestation of cancer, other than lung cancer: benign lung disease, bronchiectasis, asbestosis, or asbestos exposure. The following medical conditions are found in 5% or more of the entire population and may have lung cancer as their first manifestation: pulmonary fibrosis, pneumoconiosis, pulmonary tuberculosis, asbestosis, pleural mesothelioma, and carcinoid syndrome. The last disease, carcinoid syndrome, is primarily associated with the appendix. When found, lung cancer often coexists with another cancer at occurrence time of more than 90% of lung cancers. In most cases, these coexisting cancers are concurrently detected or occur following diagnosis of lung cancer.

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Can advanced tumors be cured?

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There is a higher cure rate for advanced tumors, compared with superficial tumors. Lymphatic invasion, extrapulmonary spread, or a high grade does not have any significant impact in the ability to cure advanced tumors. In the future, chemotherapy before surgery and radiation will have a greater impact on the success of cure for advanced tumors.

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What are the signs of advanced tumors?

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Signs of advanced tumors involve the lymph nodes. These can include pain or tenderness, as the tumor is growing within the lymph nodes, and can be felt or seen on inspection of the skin. Tumor size is not always correlated to lymph node size, but lymph node size can be an indicator of the size of the primary tumor. Tumor size may be assessed by obtaining a CT or MRI scan, or by biopsy, and its presence is often correlated to other signs of advanced tumors.

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What are common treatments for advanced tumors?

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There are many common treatments for advanced cancers of the breast, liver, brain, skin, colon, and other organs. Cancer treatment can be a painful and debilitating process that is heavily relied on by patients and their families.

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What does cpi-300 usually treat?

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Cpi-300 is a potent inhibitor of the proliferation of some tumor cells. However, in clinical practice Cpi-300 has been used for several indications (e.g. advanced metastatic breast cancer, advanced colorectal cancer), as a single agent and without major side effects. Therefore, a large Phase III trial will hopefully be initiated in order to further investigate Cpi-300 usefulness, especially as monotherapy or in combination therapy.

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What is the primary cause of advanced tumors?

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There are multiple possible primary causes for advanced tumors, including local recurrence, distant metastasis, and acquired second primary tumors. A careful examination of all tumor types is critical for identifying the precise cause for an advanced tumor and, ultimately, for establishing appropriate prognosis and treatment.

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How serious can advanced tumors be?

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Advanced tumors pose a greater threat than early tumors as long as they have metastasized before diagnosis or chemotherapy. Survival depends on local treatment. Larger tumors usually respond better to local treatment compared to small, small middle tumors. Larger tumors usually require more frequent local treatments which also have the benefit of greater improvement in overall survival.

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Is cpi-300 typically used in combination with any other treatments?

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There was no significant change in outcome between chemotherapy with CBT-300 and chemotherapy with CBT-100 when treatment was given in combination with another treatment (radiation plus chemotherapy versus radiotherapy plus hypertonic saline plus chemotherapy). The same information could be found in this study: (1) CBT-300 (compared to the control CBT-200) alone had a small impact on objective improvement; (2) hypertonic saline and chemotherapy did not improve objective benefit; and (3) radiotherapy plus conventional chemotherapy or radiotherapy alone provided no benefit compared to the control.

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Is cpi-300 safe for people?

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For people with a variety of cancer types, treatment with Cpi-300 appears to be safe. In particular, Cpi-300 appears to be safe for patients with bone and soft tissue tumors as well as cancers of the lung and colon. On the contrary, Cpi-300 does not seem to be safe for use in people with breast, pancreatic or kidney cancer. The safety of Cpi-300 is similar to that in patients treated with other chemotherapeutic agents and other immune-stimulating peptides. Given the limited data available at this time, further investigations seem warranted to clarify the safety of Cpi-300 for cancer patients.

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