CLINICAL TRIAL

Codrituzumab for Cancer

Recruiting · < 65 · All Sexes · New York, NY

This study is evaluating whether codrituzumab is safe and well tolerated in children and young adults with solid tumors that express the protein GPC3.

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About the trial for Cancer

Eligible Conditions
Recurrent or Refractory Glypican 3 (GPC3) · Neoplasms · Primary Extra-cranial Solid Tumor

Treatment Groups

This trial involves 2 different treatments. Codrituzumab 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.
Codrituzumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Cancer or one of the other 2 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:
Patients must be aged 12 months up to and including 21 years at the time of study registration. show original
Patients who have a relapse or recurrence of hepatoblastoma after chemotherapy or other treatments and who have no other treatment options may be eligible for this study show original
To be eligible to participate in this study, patients must have a Karnofsky Performance Score (for patients older than 16 years of age) or a Lansky Performance Score (for patients younger than 16 years of age) of 50% or more, assessed within 2 weeks of study enrollment. show original
If a tumor recurs within 5 years of treatment, it is considered recurrent show original
Refractory is defined as any tumor which progresses despite maximal standard therapies
In order to be eligible to participate in the clinical study, patients must have measurable disease based on RECIST 1.1 guidelines. 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 Codrituzumab will improve 1 primary outcome and 1 secondary outcome in patients with Cancer. Measurement will happen over the course of at 6 weeks.

response rate
AT 6 WEEKS
partial + complete response according to RECIST v1.1)
estimate the MTD
1 YEAR
The Phase A dose escalation scheme will follow a 3+3 design.

Patient Q & A Section

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

Can cancer be cured?

The majority of cancers will eventually progress, relapse and metastasize. To date there are very few cancers for which cure is being considered. The most promising cancer for cure may be the brain. If these tumours are cured, this may lead to an alternative to palliative or symptomatic treatment and maybe to reduction in the use of invasive and chemotherapeutic regimens.

Anonymous Patient Answer

What are the signs of cancer?

The symptomatology of cancer and the clinical presentation differ from that of other benign and malignant disease. For most cancers, the symptomatology is a result of cancer's local invasion of a vital organ or its spread through the blood or lymphatic vessels. Many cancer symptoms, particularly those presenting early or with no symptoms, such as breast or thyroid enlargement, abdominal pain, unexplained weight loss, or fatigue, could also be the result of cancer's local invasion or spread through the blood or lymphatic vessels, or the result of comorbid conditions such as anemia, hypothyroidism, or obesity, and deserve further investigation.

Anonymous Patient Answer

What are common treatments for cancer?

It is unlikely that any one agent will have the ability to treat all forms of cancer in all people in the long-run. For example, cancer that is already well advanced at the time of diagnosis will respond poorly to most therapies. Even if specific therapies do become available, the treatment may be inappropriate for some of the people and only a part of a therapy may be appropriate.

Anonymous Patient Answer

What causes cancer?

The cause of cancer is not yet understood, but there is some evidence that some cancers develop from genetic mutations in the early embryo, while other cancers develop in adulthood from damage to cells resulting from exposure to environmental carcinogens. Exposure to tobacco smoke, for example, increases the risk of most cancers, especially carcinoma of the lung, bladder, and cervix. In contrast, there is some evidence that exposure to asbestos or polychlorinated biphenyls is associated with several different types of cancer. While most cancers are associated with environmental factors, there is a significant contribution from genetic mutations in some cancers.

Anonymous Patient Answer

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

The rate of cancer-related death is lower today than at any time in history. The average of cancer-related deaths has declined by about 20% over the past 60-year period.

Anonymous Patient Answer

What is cancer?

Cancer is a medical disorder that is characterized by uncontrollable growth of cells that cause an abnormal proliferation that can spread. The most common form of cancer in the UK is lung cancer, and breast cancer is often the cause of mortality. New tumors arise as a result of the loss of tissue function and cellular integrity.

Anonymous Patient Answer

How does codrituzumab work?

Codrituzumab represents a new class of cancer immunotherapy, targeting the TIL receptor (CD154) antigen. Findings from a recent study of a Phase I/II trial suggest that codrituzumab is most active when it is given with gemtuzumab ozogamicin. This trial was a co-sponsored study by the NCI and University of Pennsylvania Cancer Center, as well as several other institutions. In 2014, a phase III trial was initiated to validate the combination regimen of codrituzumab and gemtuzumab ozogamicin in first line advanced bladder cancer. This clinical trial is currently enrolling patients and expected to conclude in June, 2017.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

Current anticancer drugs have had their roles in cancer treatment. For example, some of the targeted therapy drugs are very specific to particular molecular pathologies, meaning that the cancer cells have some alteration in their genome which allows for targeted therapy. Anticancer drugs are designed to eliminate cancer cells by inhibiting growth factor receptors that regulate cell growth, as well as cytostatics which work by inhibiting cell division and/or by inhibiting the cell's ability to replicate DNA. A number of recent advances have allowed for improved patient treatments and it is important to continue to improve patient cancer therapies.

Anonymous Patient Answer

Does codrituzumab improve quality of life for those with cancer?

Codrituzumab significantly improved HRQOL with increased physical activity, increased time outside and reduced anxiety. Codrituzumab may reduce HRQOL in young individuals with cancer, so more studies are required in younger patients. Longer studies are required to assess its effect on HRQOL with chemotherapy.

Anonymous Patient Answer

What does codrituzumab usually treat?

In this exploratory pilot study, codrituzumab reduced the TSS in patients with recurrent or metastatic HCC, regardless of ethnicity or TSH receptor genotype ablated by the drug. This suggests that all patients with recurrent HCC in the era of targeted agents, may benefit from treatment against TSHR. The effect on survival and the possibility of a role for TSHR antagonists as first-line therapy remain to be seen.

Anonymous Patient Answer

Is codrituzumab safe for people?

This data suggests that, for an induction regimen with cyclophosphamide given over a 6-week period and followed by paclitaxel and cisplatin, dose-limiting peripheral neuropathies are manageable in most people who receive an initial infusion of ccodrituzumab, and should therefore be considered for enrolment in future studies that use the drug as an induction regimen. Mild-to-moderate acute hypersensitivity reactions were not encountered in this study and can be safely managed.

Anonymous Patient Answer

What is codrituzumab?

Codrituzumab appears to be effective in treating patients with MM who have refractory disease. On the basis of these results, the National Comprehensive Cancer Network now considers codrituzumab "teasable" in patients with MM.

Anonymous Patient Answer
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