CLINICAL TRIAL

Cabozantinib S-malate for Metastatic Lung Small Cell Carcinoma

Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether a combination of two drugs may help treat cancer in patients with HIV.

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About the trial for Metastatic Lung Small Cell Carcinoma

Eligible Conditions
Metastatic Lung Small Cell Carcinoma · Sarcoma, Kaposi · Anatomic Stage IIIC Breast Cancer AJCC v8 · Recurrent Hepatocellular Carcinoma · Pathologic Stage IIID Cutaneous Melanoma AJCC v8 · Stage IVB Lung Cancer AJCC v8 · Advanced Malignant Solid Neoplasm · Recurrent Head and Neck Carcinoma · Stage IIIA2 Ovarian Cancer AJCC v8 · Advanced Lung Small Cell Carcinoma · Stage IVA Ovarian Cancer AJCC v8 · Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 · Advanced Urothelial Carcinoma · Carcinoma · Anatomic Stage III Breast Cancer AJCC v8 · Metastatic Renal Cell Carcinoma ( mRCC) · Stage IVB Ovarian Cancer AJCC v8 · Advanced Kaposi Sarcoma · Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8 · Metastatic Thyroid Gland Medullary Carcinoma · Anatomic Stage IIIA Breast Cancer AJCC v8 · Stage IIIB Lung Cancer AJCC v8 · Prognostic Stage IIIC Breast Cancer AJCC v8 · Recurrent Small Cell Lung Carcinoma · Breast Neoplasms · Metastatic Malignant Solid Neoplasm · Metastatic Triple-Negative Breast Carcinoma · Metastatic Ureter Urothelial Carcinoma · Advanced Non-Small Cell Lung Carcinoma · Metastatic Ovarian Carcinoma · Prognostic Stage IV Breast Cancer AJCC v8 · Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8 · Triple Negative Breast Carcinoma · Stage IIIA1 Ovarian Cancer AJCC v8 · Stage IIIB Ovarian Cancer AJCC v8 · Acquired Immunodeficiency Syndrome · Metastatic Melanoma · Advanced Renal Cell Carcinoma (aRCC) · Stage IIIB Hepatocellular Carcinoma AJCC v8 · Advanced Thyroid Gland Medullary Carcinoma · Recurrent Malignant Solid Neoplasm · Stage IVA Prostate Cancer AJCC v8 · Stage IVB Prostate Cancer AJCC v8 · Advanced Melanoma · Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 · Infections · HIV Infections · refractory, metastatic hormone-refractory Prostate cancer · Pathologic Stage IV Cutaneous Melanoma AJCC v8 · Stage IIIB Prostate Cancer AJCC v8 · Stage IIIC Lung Cancer AJCC v8 · Stage IIIC Prostate Cancer AJCC v8 · Recurrent Differentiated Thyroid Gland Carcinoma · Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8 · Stage IVA Lung Cancer AJCC v8 · Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 · Prognostic Stage IIIA Breast Cancer AJCC v8 · Pathologic Stage III Cutaneous Melanoma AJCC v8 · Recurrent Kaposi's Sarcoma · Recurrent Non-Small Cell Lung Carcinoma · Prognostic Stage IIIB Breast Cancer AJCC v8 · Advanced Ovarian Carcinoma · Prognostic Stage III Breast Cancer AJCC v8 · Recurrent Melanoma · Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8 · Advanced Prostate Carcinoma · Stage IVB Hepatocellular Carcinoma AJCC v8 · Stage IIIC Ovarian Cancer AJCC v8 · Carcinoma, Ovarian Epithelial · Carcinoma, Hepatocellular · Carcinoma, Renal Cell · Carcinoma, Transitional Cell · Skin Neoplasms · Carcinoma, Non-Small-Cell Lung · Carcinoma, Small Cell · Small Cell Lung Carcinoma · Carcinoma, Medullary · Thyroid Neoplasms · Carcinoma, Neuroendocrine · Thyroid Diseases · Advanced Differentiated Thyroid Gland Carcinoma · Advanced Head and Neck Carcinoma · Advanced Hepatocellular Carcinoma (HCC) · Anatomic Stage IIIB Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8 · Castration-Resistant Prostate Carcinoma · Clinical Stage III Cutaneous Melanoma AJCC v8 · Clinical Stage IV Cutaneous Melanoma AJCC v8 · Human Immunodeficiency Virus (HIV) Infections · Metastatic Differentiated Thyroid Gland Carcinoma · Metastatic Head and Neck Carcinoma · Metastatic Hepatocellular Carcinoma · Metastatic Kaposi Sarcoma · Metastatic Lung Non-Small Cell Carcinoma · Recurrent Ovarian Carcinoma · Recurrent Prostate Carcinoma · Renal Cell Carcinoma Recurrent · Recurrent Thyroid Gland Medullary Carcinoma · Recurrent Triple-Negative Breast Carcinoma · Urothelial Carcinoma Recurrent · Refractory Differentiated Thyroid Gland Carcinoma · Stage III Differentiated Thyroid Gland Carcinoma AJCC v8 · Stage III Hepatocellular Carcinoma AJCC v8 · Stage III Lung Cancer AJCC v8 · Stage III Renal Cell Cancer AJCC v8 · Stage III Thyroid Gland Medullary Carcinoma AJCC v8 · Stage IIIA Hepatocellular Carcinoma AJCC v8 · Stage IIIA Lung Cancer AJCC v8 · Stage IIIA Ovarian Cancer AJCC v8 · Stage IIIA Prostate Cancer AJCC v8 · Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 · Stage IV Hepatocellular Carcinoma AJCC v8 · Stage IV Lung Cancer AJCC v8 · Stage IV Ovarian Cancer AJCC v8 · Stage IV Prostate Cancer AJCC v8 · Stage IV Renal Cell Cancer AJCC v8 · Stage IV Thyroid Gland Medullary Carcinoma AJCC v8 · Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 · Stage IVA Hepatocellular Carcinoma AJCC v8 · Lung Neoplasms · Prostatic Neoplasms · Neoplasms · Melanoma · Sarcoma · Ovarian Neoplasms · Stage III Ovarian Cancer AJCC v8 · Stage III Prostate Cancer AJCC v8

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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cabozantinib S-malate
DRUG
Nivolumab
BIOLOGICAL
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
Nivolumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Metastatic Lung Small Cell Carcinoma or one of the other 126 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:
People with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 80%) are considered to have a good prognosis. show original
Age >= 18 years. Children are excluded from this study, but will be eligible for future pediatric trials
Subjects who have tumors that are not KS must have evaluable disease. show original
People who have received cancer treatments in the past are allowed to participate in this trial, as are people who have never received cancer treatments before 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: 28 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 28 days.
View detailed reporting requirements
Trial Expert
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- 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 1 primary outcome, 2 secondary outcomes, and 4 other outcomes in patients with Metastatic Lung Small Cell Carcinoma. Measurement will happen over the course of Baseline up to 16 weeks post treatment.

Change in angiogenesis markers
BASELINE UP TO 16 WEEKS POST TREATMENT
Changes in angiogenesis markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.
Change in serum markers of immune activation
BASELINE UP TO 16 WEEKS POST TREATMENT
Change in serum markers of immune activation- immune cell subsets and cytokine levels at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Will correlate markers of immune activation and expansion of immune cell subsets and cytokines with clinical outcome.
Change in infiltrating immune cell markers
BASELINE UP TO 16 WEEKS POST TREATMENT
Changes in infiltrating immune cell markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.
Change in immune checkpoint markers
BASELINE UP TO 16 WEEKS POST TREATMENT
Changes in immune checkpoint (PD-L1, B7x, B7-H3, HHLA2) markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.
Immune status
UP TO 16 WEEKS POST TREATMENT
Will assess immune status (CD4 and CD8 cell counts). Changes in immune status at each time point from baseline will be analyzed using paired non-parametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.
Human immunodeficiency virus (HIV) viral loads
UP TO 16 WEEKS POST TREATMENT
Will assess HIV viral loads. Changes in viral loads at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.
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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.

What is carcinoma, ovarian epithelial?

Carcinoma, ovarian epithelial is a cancer formed in the ovary, and typically spreads to other parts of the body. This cancer is usually discovered early in a woman's life, because of the symptoms.\n

Anonymous Patient Answer

Can carcinoma, ovarian epithelial be cured?

[Even though the incidence of advanced stage, grade III-IV, and bulky carcinoma is higher than of stage-involves, we have not found, until now, differences in long-term prognosis, with no evidence of metastatic, locally recurred metastases or locoregional progression (LRP)(HIT B-4) in our center]. [Moreover, this has not led to change in treatment plan (i.e., surgery or chemotherapy) for our patients with advanced stage carcinoma, grade III-IV, and bulky carcinoma.

Anonymous Patient Answer

What are common treatments for carcinoma, ovarian epithelial?

Women with carcinoma, ovarian epithelial of any stage should receive chemotherapy unless they cannot tolerate this treatment. Most patients are monitored for the potential emergence of secondary tumors while they are being treated.

Anonymous Patient Answer

What are the signs of carcinoma, ovarian epithelial?

The signs of carcinoma, ovarian epithelial, include pelvic pain, adnexa enlargement, dyspareunia, an absent, a hard, or a thick PRA, frequent or painful urination, a palpable pelvic mass, dysuria, fatigue, and abdominal discomfort.

Anonymous Patient Answer

What causes carcinoma, ovarian epithelial?

The vast majority of carcinomas from the ovary are associated with borderline or diffuse, rather than papillary, trophoblast cells. Papillary trophoblast cells may secrete large amounts of proinflammatory factors which could explain the increased proliferation seen in ovarian cancers. This contrasts with adenosarcina, where most lesions are predominantly borderline cells.

Anonymous Patient Answer

How many people get carcinoma, ovarian epithelial a year in the United States?

The data in this report is preliminary given that the overall number of people are not differentiated by gender and by race/ethnicity. The lack of data on the overall annual risk of OC may not reflect a true distribution of OC in a population.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, ovarian epithelial?

Although some clinical trials on carcinoma or ovarian epithelial are conducted in patients with different cancer types, enrollment of patients with a common type of this cancer is recommended.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, ovarian epithelial?

For most patients with malignant COC or epithelial [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer), the current therapeutic approach can achieve reasonably good response rates. However, for a small number of these patients, the treatment may not be effective even though the number of cycles might be increased. The overall survival was also lower than expected among women with COC who received chemotherapy. This may be related to the fact that the chemotherapy-induced COC is a chemoresistant cancer, because chemotherapy might alter the biochemistry of the cancer cells.

Anonymous Patient Answer

What are the common side effects of cabozantinib s-malate?

The common adverse events reported in these studies were typical of the indications for cabozantinib, including constipation, fatigue, headache, diarrhea, fatigue, nausea, dizziness, and rash. However, no major difference in tolerability was observed across indications, including those not targeted by cabozantinib, and no indication-specific information was found in the published studies.

Anonymous Patient Answer

What is the primary cause of carcinoma, ovarian epithelial?

The present study provides evidence to indicate that carcinoma, ovarian epithelial is the most common benign primary mass in the ovary. Therefore, when evaluating patients with ovarian neoplasms, medical imaging techniques can play a very important role as they assist in differentiating between benign and malignant tumors.

Anonymous Patient Answer

Does cabozantinib s-malate improve quality of life for those with carcinoma, ovarian epithelial?

In patients with carcinoma, cabozantinib improves QOL in all three domain areas examined, in both healthy and diseased subjects. QOL is not limited to improvements in nausea and pain and can be extended to improvements in overall distress and physical functioning. Combining cabozantinib oncology therapy with other treatments may be a means by which patients with cancer may be able to improve their QOL.

Anonymous Patient Answer

Does carcinoma, ovarian epithelial run in families?

Despite recent studies demonstrating a genetic basis for O-CRL, O-CRLs themselves are often found in families, a finding consistent with a genetic etiology for the disease. It is hypothesized that O-CRLs are due to a low-hanging fruit of genetic predisposition.

Anonymous Patient Answer
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