Ribociclib for Unresectable Malignant Peripheral Nerve Sheath Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Unresectable Malignant Peripheral Nerve Sheath Tumor+36 More
Ribociclib - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating the side effects and best dose of ribociclib when given together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop

See full description

Eligible Conditions

  • Unresectable Malignant Peripheral Nerve Sheath Tumor
  • Unresectable Soft Tissue Sarcoma
  • advanced Soft Tissue Sarcoma (STS)
  • Metastatic Epithelioid Sarcoma
  • Unresectable Leiomyosarcoma
  • Undifferentiated (Embryonal) Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Locally Advanced Liposarcoma
  • Metastatic Soft Tissue Sarcoma
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Locally Advanced Myxofibrosarcoma
  • Metastatic Myxofibrosarcoma
  • Pleomorphic Rhabdomyosarcoma
  • Locally Advanced Undifferentiated Pleomorphic Sarcoma
  • Unresectable Synovial Sarcoma
  • Metastatic Angiosarcoma
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Metastatic Synovial Sarcoma
  • Metastatic Fibrosarcoma
  • Locally Advanced Leiomyosarcoma
  • Metastatic Malignant Peripheral Nerve Sheath Tumor
  • Locally Advanced Angiosarcoma
  • Unresectable Undifferentiated Pleomorphic Sarcoma
  • Locally Advanced Malignant Peripheral Nerve Sheath Tumor
  • Metastatic Liposarcoma
  • Unresectable Liposarcoma
  • Myxofibrosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Unresectable Malignant Peripheral Nerve Sheath Tumor

Study Objectives

This trial is evaluating whether Ribociclib will improve 1 primary outcome and 4 secondary outcomes in patients with Unresectable Malignant Peripheral Nerve Sheath Tumor. Measurement will happen over the course of Up to 21 days.

Month 12
Progression-free survival (PFS)
Up to 12 months
Incidence of adverse events, SAEs
Incidence of dose modifications (interruptions, reductions, intensity) due to adverse events
Objective response rate (ORR)
Up to 21 days
Incidence of dose limiting toxicities (DLTs) of adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Unresectable Malignant Peripheral Nerve Sheath Tumor

Trial Design

1 Treatment Group

Treatment (ribociclib, doxorubicin hydrochloride)
1 of 1
Experimental Treatment

This trial requires 16 total participants across 1 different treatment group

This trial involves a single treatment. Ribociclib 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.

Treatment (ribociclib, doxorubicin hydrochloride)Patients receive ribociclib PO daily on days 1-7, and doxorubicin hydrochloride IV on day 10. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Ribociclib
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
L. D.
Lara Davis, Principal Investigator
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Synovial sarcoma
Fibrosarcoma
Undifferentiated sarcoma
Liposarcoma
Leiomyosarcoma
Angiosarcoma
A tumor that affects the peripheral nerves show original
is a rare type of sarcoma show original
Epithelioid sarcoma
Undifferentiated pleomorphic sarcoma

Patient Q&A Section

What are common treatments for sarcoma?

"Treatment of sarcoma often includes chemotherapy, radiation therapy, or surgery. Surgery may be required in case of metastatic disease, but no adjuvant therapy is routinely provided. A palliative-care approach may be of value." - Anonymous Online Contributor

Unverified Answer

What are the signs of sarcoma?

"Cancers of the breast, lung, skin, stomach, and kidney are diagnosed in the majority of women presenting with symptoms of sarcoma. Early onset of symptoms of sarcoma does not appear to predict more extensive disease. The presence of lymphedema or mass lesion indicates an increased risk for local recurrence in the extremities and should not be ignored." - Anonymous Online Contributor

Unverified Answer

How many people get sarcoma a year in the United States?

"The new American Cancer Society estimates for sarcoma incidence in the United States for years 1990 through 2002 are 3,700 (2,800 new cases per year in 1991 and 3,600 in 2000). The incidence rate of sarcoma is 4.3 cases per 100,000 population per year in the United States. These estimates provide the basis for estimating the number of new cases of sarcomAa in the United States annually." - Anonymous Online Contributor

Unverified Answer

What causes sarcoma?

"Most sarcomas have well defined risk factors, but it is also possible for the development of one or two risk factors to be enough to start the cancer in a person. Most sarcomas are caused by a genetic or metabolic disorder. The risk of sarcoma increases with age.\n\n- Epidemiology of leukemia"" - Anonymous Online Contributor

Unverified Answer

Can sarcoma be cured?

"Sarcoma can be cured for only 20% to 40% of patients. At present, the majority of patients have unresectable metastatic or local recurrences following surgery and/or radiation therapy. Novel therapies that target the bone microenvironment or specific tumour stromal cells may improve the success of treatment. Ongoing clinical trials will seek to clarify the role of surgery plus radiotherapy, chemotherapy and biological treatments in sarcoma." - Anonymous Online Contributor

Unverified Answer

What is sarcoma?

"Sarcomas are malignant mesenchymal neoplasms that are part of a complex tumor microenvironment made up of cancer cells and stromal components (connective tissue cells). They occur most commonly in individuals over the age of 50 years and are more common in males than females.\n" - Anonymous Online Contributor

Unverified Answer

What are the chances of developing sarcoma?

"Data from a recent study show that the probability of a future diagnosis of a sarcoma is higher among those diagnosed with myeloproliferative or lymphoproliferative disorders than among those diagnosed without such disorders. Patients diagnosed with a myeloproliferative disorder had a 3.76-fold increased risk of developing a sarcoma and those with a lymphoproliferative disorder had a 1.73-fold increased risk." - Anonymous Online Contributor

Unverified Answer

How quickly does sarcoma spread?

"This has direct implications for the treatment of locally advanced tumours and treatment by external radiotherapy with curative intention, thereby decreasing the time that tumours spread to other organs, with potential clinical and therapeutic implications - not least of which, the decreased chances of local tumour recurrence. (11, 12 ) It is of utmost importance that sarcoma patients are diagnosed and treated as quickly as possible, which will decrease the time interval between disease onset and patient mortality in comparison with more advanced cancers. Early clinical diagnosis decreases the spread of the disease to nearby and distant sites and promotes the development of effective treatment protocols." - Anonymous Online Contributor

Unverified Answer

What is the latest research for sarcoma?

"The major recent publications are reviewed here. It is now extremely clear that, with all the discoveries in these areas, there are likely to be many more, in the future, such as will require major investment of medical research funding in sarcoma and other cancers." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ribociclib?

"Most of the clinical trials investigating nintedanib and lenvatinib did not have a ribociclib arm as a comparator. These trials should be extended to allow for a more rigorous test of the hypothesis that they prevent PFS compared to ribociclib." - Anonymous Online Contributor

Unverified Answer

Has ribociclib proven to be more effective than a placebo?

"The data suggest that ribociclib-CHD-R is more effective than a placebo in patients with advanced breast cancer receiving trastuzumab and taxane. The use of ribociclib-CHD-R could also decrease the risk of progression by a meaningful amount when added to first-line chemotherapy for advanced breast cancer." - Anonymous Online Contributor

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