CLINICAL TRIAL

Cabozantinib S-malate for Osteosarcoma

Waitlist Available · < 65 · All Sexes · Des Moines, IA

This study is evaluating whether cabozantinib-s-malate is effective in treating sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed.

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About the trial for Osteosarcoma

Eligible Conditions
Central Nervous System Neoplasms · Recurrent Clear Cell Sarcoma of Soft Tissue · Refractory Thyroid Gland Medullary Carcinoma · Recurrent Kidney Wilms Tumor · Refractory Renal Cell Carcinoma · Refractory Clear Cell Sarcoma of Soft Tissue · Refractory Hepatoblastoma · Solid Neoplasms · Adrenocortical Carcinoma · refractory, primary Central Nervous System Neoplasm · Hepatocellular Carcinoma · Recurrent Soft Tissue Sarcoma · Thyroid Gland Medullary Carcinoma · Carcinoma, Renal Cell · Refractory Osteosarcoma · Refractory Hepatocellular Carcinoma · Recurrent Adrenal Cortex Carcinoma · Recurrent Primary Malignant Central Nervous System Neoplasm · Recurrent Thyroid Gland Medullary Carcinoma · Recurrent Osteosarcoma · Renal Cell Adenocarcinoma · Childhood Clear Cell Sarcoma of Soft Tissue · Recurrent Alveolar Soft Part Sarcoma · Sarcoma · Refractory Rhabdomyosarcoma · Clear Cell Sarcoma of Soft Tissue · Refractory Ewing Sarcoma · recurrent Ewing's Sarcoma · Recurrent Hepatocellular Carcinoma · Ewing Sarcoma · Thyroid Diseases · Neoplasms · Rhabdomyosarcoma · Nervous System Neoplasms · Thyroid Neoplasms · Adrenal Cortex Carcinoma · Alveolar Soft Part Sarcoma (ASPS) · Osteosarcoma · Recurrent Rhabdomyosarcoma · Recurrent Hepatoblastoma · Recurrent Malignant Solid Neoplasm · Refractory Malignant Solid Neoplasm · Refractory Primary Malignant Central Nervous System Neoplasm · Refractory Soft Tissue Sarcomas · Hepatoblastoma · Carcinoma, Medullary · Carcinoma, Neuroendocrine · Sarcoma, Clear Cell · Wilms Tumor · Carcinoma · Sarcoma, Alveolar Soft Part · Carcinoma, Hepatocellular · Sarcoma, Ewing · Renal Cell Carcinoma Recurrent

Treatment Groups

This trial involves 2 different treatments. Cabozantinib S-malate 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 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cabozantinib
DRUG
Cabozantinib S-malate
DRUG
Pharmacological Study
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Cabozantinib
FDA approved

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Osteosarcoma or one of the other 53 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) =< 30 years for all other diagnoses
Ewing sarcoma
Rhabdomyosarcoma (RMS)
Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS])
You have osteosarcoma. show original
You have a diagnosis of Wilms tumor. show original
Medullary thyroid carcinoma (MTC)
Renal cell carcinoma (RCC)
Hepatocellular carcinoma (HCC)
You have a body surface area > 0.35 m^2. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cabozantinib S-malate will improve 2 primary outcomes, 8 secondary outcomes, and 1 other outcome in patients with Osteosarcoma. Measurement will happen over the course of Up to the first 6 cycles of therapy..

Objective response (Osteosarcoma Stratum)
UP TO THE FIRST 6 CYCLES OF THERAPY.
Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design
Objective response
UP TO THE FIRST 6 CYCLES OF THERAPY
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design.
Change in immune biomarkers
BASELINE, DAY 1 (PRIOR TO DOSE) OF CYCLES 2 AND 3
The association between the host immune system and response to cabozantinib-s-malate will be assessed in an exploratory manner. each biomarker will be correlated with the clinical outcomes of objective response and progression free survival.
Incidence of adverse events
UP TO 5 YEARS (DURATION OF PROTOCOL THERAPY PLUS 30 DAYS AFTER LAST DOSE OF THERAPY)
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
Pharmacokinetics (PK) parameters of cabozantinib s-malate: Accumulation
CYCLE 1, DAY 1 (20-28 HOURS AFTER DOSE) AND CYCLE 1, DAY 22
PK accumulation will be summarized by the mean and the standard deviation.
Pharmacokinetics (PK) parameters of cabozantinib s-malate: Half-life
CYCLE 1, DAY 1 (20-28 HOURS AFTER DOSE) AND CYCLE 1, DAY 22
PK half-life will be summarized by the mean and the standard deviation.
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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 osteosarcoma a year in the United States?

Every year, around 12,600 people get osteosarcoma, making it the second most common cancer in American men. This is a significant health issue that needs new treatments.

Anonymous Patient Answer

Can osteosarcoma be cured?

Can osteosarcoma be cured? The chances of cure are better with earlier detection and treatment. Patients with osteosarcoma who are treated within the first year of diagnosis have an >8 times greater chance of cure. Patients with osteosarcoma of either genders have a better chance of cure if they are treated within the first year.

Anonymous Patient Answer

What are the signs of osteosarcoma?

The most common symptoms of osteosarcoma are painless metastatic lesions in a child that do not respond to treatment, and an increasing grade/size of the primary lesion in the absence of signs of disease spread. The most common sites of metastatic lesions are the lungs and pelvis; less common sites are the thyroid, skin (primary, secondary), and bone (primary, secondary). It is necessary to rule out metastatic disease before the diagnosis of skeletal osteosarcoma is made.

Anonymous Patient Answer

What is osteosarcoma?

Osteosarcoma is a rare cancer that forms in the bone. It typically arises in children and teenagers between the ages of 10 and 30 years old with boys being more often affected than girls. A history of heavy smoking may increase the risk. Osteosarcoma is a tumor that occurs in the bone, and presents as an abnormal shape in the bone that may become painful.

Anonymous Patient Answer

What are common treatments for osteosarcoma?

Recent findings defines common cancer treatments for osteosarcoma. All patients treated with a surgical resection are generally at some stage of clinical remission by one year after surgery. Radiotherapy is frequently an adjunctive treatment for patients who were not candidates for surgery. Chemotherapy and adjuvant therapy protocols vary greatly across the literature but are typically based on the local disease extent. We suggest that as the majority of patients with osteosarcoma are candidates for definitive surgical management, there is an opportunity for improvement in survival.

Anonymous Patient Answer

What causes osteosarcoma?

Studies have indicated that factors, in the environment as well as genetic, play an important role in the development of osteosarcoma. Smoking, alcohol, drugs, physical trauma, and infectious agents all may trigger an increased risk of developing this type of cancer. It is also known that the occurrence of osteosarcoma is less common in Asians than Caucasians.\n

Anonymous Patient Answer

How quickly does osteosarcoma spread?

Osteosarcoma does not seem to grow as rapidly as most cancers. However, the extent of the metastasis still varied significantly, and we have not seen much of a difference between the incidence of osteosarcoma cancer and metastatic osteosarcoma. All cases are treated with surgery though, however, in all patients there can be tumour cells in areas that are surgically inaccessible for long periods. We have seen a clear correlation in our patient pool with an increasing incidence of metastases over time, which is likely at least partly the result of our own treatment strategies rather than the presence of metastases on their own.

Anonymous Patient Answer

How does cabozantinib s-malate work?

Cabozantinib s-malate inhibits Hsp90-mediated functions including chaperone gene expression in SKOV3 cell lines in vitro. Further in vivo studies are warranted to clarify its effects, and if effective, its role in bone and tissue regeneration.

Anonymous Patient Answer

Has cabozantinib s-malate proven to be more effective than a placebo?

Cabozantinib, which acts as MET and VEGFR2 dual kinase inhibitor, is an effective treatment in a subset of patients with advanced sarcoma. It will be interesting to see how many patients respond to a second dosing of cabozantinib.

Anonymous Patient Answer

What is the survival rate for osteosarcoma?

Although there were no clear disparities between treatment facilities, the survival rate of osteosarcoma patients was not higher than that for other cancer patients. The low prevalence of distant metastases is the most important prognostic factor. We should, perhaps, consider a more aggressive treatment strategy for patients who have metastases.

Anonymous Patient Answer

What are the latest developments in cabozantinib s-malate for therapeutic use?

This agent is a promising therapy for patients with RAS wild-type advanced or metastatic solid tumors but has not finished phase III clinical trials. Further studies have suggested its activity as a single-agent, first-line treatment for metastatic renal cell carcinoma (RCC) patients and warrants further clinical study.

Anonymous Patient Answer

What is the latest research for osteosarcoma?

This is very important because one should be on the lookout for new developments in the disease. There is new research for osteosarcoma that may yield more information on some prognostic factors of the disease and also its treatment. It is clear from this research that the prognosis still remains the same but our knowledge about the condition has grown bigger and better. For research to go ahead smoothly we need to come together and work together to raise the levels of awareness for our condition and get our voice heard.

Anonymous Patient Answer
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