Clinical trial for Endocrine Tumors
Official title Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
ClinicalTrials.gov ID: NCT03412877
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for endocrine tumors.
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: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible.
- Phase 2: a mid-size study of how well it works
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
- Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers
- Documented diagnosis of cancer.
- Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.
- Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.
- Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when...
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.
- For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- History of major organ autoimmune disease.
See the full eligibility criteria
- Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC)
- Documented diagnosis of cancer.
- Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.
- Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.
- Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).
- Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as...
- Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38...
- Participants with three (3) or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible.
- Age greater than or equal to 18 years and less than or equal to 72 years.
- Clinical performance status of ECOG 0 or 1.
- Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing...
- Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.
- Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system.
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant 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.
- Serum ALT/AST less than or equal to 5.0 x ULN
- Serum creatinine less than or equal to 1.6 mg/dL.
- Total bilirubin less than or equal to 2.0 mg/dL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg/dL.
- Participants must have completed any prior systemic therapy at the time of enrollment. Note: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to...
- For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have...
- 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.
- For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- History of major organ autoimmune disease.
- For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1, including but not limited to myocarditis and pneumonitis.
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system.
- History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
- For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.
- History of coronary revascularization or ischemic symptoms.
- For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
- For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.
- Participants who are receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.