BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
ClinicalTrials.gov ID: NCT01174121
What this study is testing
What is Pembrolizumab (Keytruda)?
Pembrolizumab (Keytruda) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 72
You may be able to join if
- Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary...
- Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.
- Refractory to approved standard systemic therapy. Specifically:
- Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.
- Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.
You likely can't join if
- Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Concurrent systemic steroid therapy.
- Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
- Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- History of major organ autoimmune disease.
See the full eligibility criteria
- Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including...
- Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.
- Refractory to approved standard systemic therapy. Specifically:
- Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.
- Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.
- Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.
- Patients with 3 or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment...
- Age greater than or equal to 18 years and less than or equal to 72 years.
- Clinical performance status of ECOG 0 or 1.
- Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP)...
- IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus. Serology
- Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less...
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative...
- ANC \> 1000/mm\^3 without the support of filgrastim
- WBC greater than or equal to 2500/mm\^3
- Platelet count greater than or equal to 80,000/mm\^3
- Hemoglobin \> 8.0 g/dL. people may be transfused to reach this cut-off. Chemistry
- Serum ALT/AST less than or equal to 5.0 x ULN
- Serum creatinine less than or equal to 1.5 x ULN
- Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \< 3.0 mg/dL.
- Patients must have completed any prior systemic therapy at the time of enrollment. Note: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as...
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willing to sign a durable power of attorney.
- people must be co-enrolled on protocol 03-C-0277.
- Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Concurrent systemic steroid therapy.
- Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
- Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- History of major organ autoimmune disease.
- Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy.
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the...
- History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
- History of coronary revascularization or ischemic symptoms.
- For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
- Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.
- For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.
- Patients who are receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.