CLINICAL TRIAL

Trastuzumab for Lymphoma

Metastatic
Refractory
Stage I
Recruiting · 18+ · All Sexes · Modesto, CA

This study is evaluating whether genetic testing may help determine the best treatment for patients with solid tumors or lymphomas.

See full description

About the trial for Lymphoma

Eligible Conditions
Lymphoma · Carcinoma, Hepatocellular · Esophageal Carcinoma · Head and Neck Carcinoma · Recurrent Liver Carcinoma · Thyroid Neoplasms · Gastric Carcinoma · Glioma · Malignant Uterine Neoplasm · Neoplasms, Plasma Cell · Pancreatic Neoplasms · Renal Carcinoma · Carcinoma, Ovarian Epithelial · Colon Carcinoma · Melanoma · Uterine Neoplasms · Carcinoma, Renal Cell · Thyroid Diseases · Advanced Malignant Solid Neoplasm · Cervical Carcinoma · Lung, Carcinoma · Prostate Cancer · Recurrent Gliomas · Recurrent Head and Neck Carcinoma · Refractory Plasma Cell Myeloma · Uterine Corpus Cancer · Carcinoma · Colorectal Neoplasms · Ovarian Neoplasms · Prostatic Neoplasms · Esophageal Neoplasms · Urinary Bladder Neoplasms · Stomach Neoplasms · Ovarian Carcinoma · Recurrent Breast Carcinoma · Recurrent Cervical Carcinoma · Recurrent Colon Carcinoma · Recurrent Lung Carcinoma · Recurrent Uterine Corpus Cancer · Skin Carcinoma · Colorectal Carcinoma (CRC) · Recurrent Bladder Carcinoma · Recurrent Colorectal Carcinoma · Recurrent Esophageal Carcinoma · Recurrent Gastric Carcinoma · Recurrent Lymphoma · Recurrent Malignant Solid Neoplasm · Recurrent Ovarian Carcinoma · Recurrent Pancreatic Carcinoma · Recurrent Prostate Carcinoma · Recurrent Rectal Carcinoma · Recurrent Thyroid Gland Carcinoma · Thyroid Gland Carcinoma · Liver and Intrahepatic Bile Duct Carcinoma · Carcinoma, Pancreatic · Plasma Cell Myeloma · Rectal Carcinoma · Recurrent Melanoma · Recurrent Plasma Cell Myeloma · Refractory Lymphomas · Refractory Malignant Solid Neoplasm · Neoplasms · Skin Neoplasms · Endometrial Carcinoma · Recurrent Skin Carcinoma · Multiple Myeloma · Endometrial Neoplasms · Rectal Neoplasms · Kidney Neoplasms · Bladder Carcinoma · Breast Carcinoma · Breast Neoplasms · Lung Neoplasms · Colonic Neoplasms

Treatment Groups

This trial involves 38 different treatments. Trastuzumab is the primary treatment being studied. Participants will be divided into 38 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Cytology Specimen Collection Procedure
OTHER
+
Vismodegib
DRUG
+
Laboratory Biomarker Analysis
OTHER
Experimental Group 2
Cytology Specimen Collection Procedure
OTHER
+
Trametinib
DRUG
+
Dabrafenib Mesylate
DRUG
+
Dabrafenib
DRUG
+
Laboratory Biomarker Analysis
OTHER
Experimental Group 3
Nivolumab
BIOLOGICAL
+
Cytology Specimen Collection Procedure
OTHER
+
Laboratory Biomarker Analysis
OTHER
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Afatinib
FDA approved
Nivolumab
FDA approved
Osimertinib
FDA approved
Sunitinib
FDA approved
Taselisib
Not yet FDA approved
Trastuzumab emtansine
FDA approved
Palbociclib
FDA approved
Copanlisib
FDA approved
Ipatasertib
Not yet FDA approved
Tyrosine
FDA approved
Trametinib
FDA approved
Vismodegib
FDA approved
Methane
Not yet FDA approved
Erdafitinib
FDA approved
MK-1775
Not yet FDA approved
Afatinib
FDA approved
Binimetinib
FDA approved
Capivasertib
Not yet FDA approved
Dabrafenib
FDA approved
Dasatinib
FDA approved
Defactinib
Not yet FDA approved
FGFR Inhibitor AZD4547
2014
Completed Phase 3
~1960
Pertuzumab
FDA approved
Sapanisertib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. 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:
will also be eligible Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e show original
that has not responded to standard therapy Patients must have a disease that can be measured and that has not responded to standard therapy. show original
ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
At some point, the person has achieved menarche. show original
has not had a hysterectomy, has not had bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months. show original
People who participate in this study cannot expect to get pregnant or father children using accepted and effective methods of contraception or by not having sex before entering the study, during the study, and for four months after finishing the study show original
Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
has about a five-year survival rate The currently available five-year survival rate for adequately treated stage I or II cancer from which the patient is currently in complete remission is about five years. show original
Any other cancer from which the patient has been disease-free for 5 years
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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 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
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 Trastuzumab will improve 1 primary outcome and 2 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of From entry onto that step until determination of disease progression or death from any cause, censored at the date of last disease assessment for patients who have not progressed, assessed at 6 months.

Progression free survival
FROM ENTRY ONTO THAT STEP UNTIL DETERMINATION OF DISEASE PROGRESSION OR DEATH FROM ANY CAUSE, CENSORED AT THE DATE OF LAST DISEASE ASSESSMENT FOR PATIENTS WHO HAVE NOT PROGRESSED, ASSESSED AT 6 MONTHS
Progression free survival will be estimated using the Kaplan-Meier method. For each treatment arm, 90% two-sided confidence intervals will be calculated.
FROM ENTRY ONTO THAT STEP UNTIL DETERMINATION OF DISEASE PROGRESSION OR DEATH FROM ANY CAUSE, CENSORED AT THE DATE OF LAST DISEASE ASSESSMENT FOR PATIENTS WHO HAVE NOT PROGRESSED, ASSESSED AT 6 MONTHS
Overall survival
FROM REGISTRATION ONTO THAT STEP UNTIL DEATH, OR CENSORED AT THE DATE OF LAST CONTACT, ASSESSED UP TO 3 YEARS
Will be evaluated specifically for each drug (or step). Overall survival will be estimated using the Kaplan-Meier method.
FROM REGISTRATION ONTO THAT STEP UNTIL DEATH, OR CENSORED AT THE DATE OF LAST CONTACT, ASSESSED UP TO 3 YEARS
Objective response rate
UP TO 3 YEARS
Defined as the percentage of patients whose tumors have a complete or partial response to treatment. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria for solid tumors, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided confidence intervals will be calculated.
UP TO 3 YEARS

Patient Q & A Section

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

Have there been other clinical trials involving crizotinib?

The clinical trial on crizotinib that has been reported in Lancet New England Journal of Medicine shows that a targeted therapy is active against metastatic breast cancer, which is not so widely metastatic at the time of diagnosis.

Anonymous Patient Answer

What are the signs of breast cancer?

In [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), there is often a sore, swollen lump, or nipple change. Breast disease can also cause breast pain, a change in size of the lump, skin changes at the site or nipple, or nipple discharge. Women should consult a health professional if they have any of these symptoms.

Anonymous Patient Answer

What are common treatments for breast cancer?

The most common treatment regimen for breast cancer in the United States is the lumpectomy with radiation. The second most common was the lumpectomy without radiation. Nearly all patients who received lumpectomy experienced a recurrence of the disease within five years. Radiation was most often used to treat the recurrence. Overall, lumpectomy was an effective treatment for a substantial number of women with breast cancer in the United States.

Anonymous Patient Answer

Can breast cancer be cured?

A prospective, randomized trial of women with newly diagnosed breast cancer and high-risk profiles would support the hypothesis that mammographic detection has improved so that earlier breast cancer detection may be safer from the perspective of women's health, and a randomized trial would provide the strongest evidence of benefit from mammographic screening.

Anonymous Patient Answer

What is breast cancer?

Breast cancers can be prevented by avoiding tobacco and alcohol use, regular screening examinations and by getting tested at an early age. Breast cancer can be cured and you have a better chance of a full and active life if you are treated quickly and have surgery within 3-4 weeks of the discovery of an early symptom.\n

Anonymous Patient Answer

What causes breast cancer?

There is considerable room for research investigating the causes of breast cancer. There also appears to be some evidence that breast cancer is more common among the elderly, in people who had previously had breast cancer, and who live in northern European or western European countries. It also appears that factors that affect pregnancy-related risk of breast cancer may also be of importance.

Anonymous Patient Answer

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

The average incidence estimate for diagnosed [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is 62 per 100,000 women aged 40 years and above, with a standard error of about 10 per 100,000 women. However, the incidence was estimated to be as low as 29 per 100,000 women aged 40–59 years with a standard error of about 7 and as high as 80 per 100,000 women aged 60 years and above with a standard error of about 15. There were no statistically significant differences in the incidence of cancer diagnosed by age or gender. More people need to be diagnosed with breast cancer at younger ages to make a difference in mortality.

Anonymous Patient Answer

What does crizotinib usually treat?

Although some patients are responsive to crizotinib, our findings suggest that, in general, crizotinib is an effective drug in treatment of ALK-positive metastatic breast cancer and can be safely added to the therapeutic regimen in the majority of cases.

Anonymous Patient Answer

What is the primary cause of breast cancer?

Although there is sufficient evidence that risk factors such as obesity, endocrine disruptors, and nulliparity greatly increase women's risk of breast cancer, there is also sufficient evidence of an inverse association to support the endocrine hypothesis.

Anonymous Patient Answer

What is the survival rate for breast cancer?

Breast cancer survival rates in the United States are generally poor compared to other countries despite the fact that the treatment protocols are the same in many areas. These outcomes may be affected by race, race-related biological characteristics, gender, age, location of the disease, and genetic predisposition.

Anonymous Patient Answer

Is crizotinib safe for people?

Crizotinib was well tolerated in people with metastatic non-small cell lung cancer (M-NSCLC) or locally advanced or metastatic non-small cell lung cancer (NSCLC) who were previously treated with two or more line(s) of first line chemotherapy, and was associated with durable responses, as well as a low rate of CNS and intracranial events. Determining optimal second-line therapy with crizotinib warrants further study.

Anonymous Patient Answer

What is crizotinib?

Crizotinib (Xalkori) is approved as the first line treatment for metastatic non-small cell lung cancer (NSCLC). However, the drug has also been approved in India as second line treatment for NSCLC treatment. In phase 3 clinical trial it demonstrated good efficacy in combination therapy for metastatic NSCLC (ESMO-EORTC 10012 trial). Therefore it should be regarded as an important reference for NSCLC patients. One of major issue of crizotinib use is its adverse effect on patient.

Anonymous Patient Answer
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