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A non-personalized version of the “NIH TIL Trial” for patients who have both: 1.) KRAS G12V mutation and 2.) HLA-A*1101

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Criterios de inclusión

* CRITERIOS DE INCLUSIÓN:
* Measurable (per RECIST V1.1 criteria, metastatic, or unresectable malignancy expressing G12V mutated KRAS as assessed by one of the following methods: RT-PCR on tumor tissue, tumor DNA sequencing, or any other CLIA-certified laboratory test on resected tissue. Patients shown to have tumors expressing G12V mutated NRAS and HRAS will also be eligible as these oncogenes share complete amino acid homology with G12V mutated KRAS for their first 80 N-terminal amino acids, completely encompassing the target epitope.
* Patients must be HLA-A*11:01 positive as confirmed by the NIH Department of Transfusion Medicine.
* Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.
* Patients must have:

* previously received standard systemic therapy for their advanced cancer and have been either non-responders or have recurred, specifically:

* Los pacientes con cáncer colorrectal metastásico deben haber recibido al menos dos regímenes de quimioterapia sistémica que incluyan 5FU, leucovorina, bevacizumab, oxaliplatino e irinotecán (o agentes similares), o tener contraindicaciones para recibir esos medicamentos.
* Los pacientes con cáncer de páncreas deben haber recibido gemcitabina, 5FU y oxaliplatino (o agentes similares), o tener contraindicaciones para recibir esos medicamentos.
* Patients with non-small cell lung cancer (NSCLC) must have had appropriate targeted therapy as indicated by abnormalities in ALK, EGFR, or expression of PDL- 1. Other patients must have had platinum-based chemotherapy.
* Los pacientes con cáncer de ovario o de próstata deben haber recibido quimioterapia de primera línea aprobada.

O

* declined standard treatment
* Patients with 3 or fewer brain metastases that are less than 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 for the patient to be eligible. Patients

with surgically resected brain metastases 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
* Patients 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 women and for 4 months after treatment for men.
* Women of child-bearing potential must be willing to undergo pregnancy testing prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.

NOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and/ or ultrasound may be performed for clarification.

* 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 responsive to the experimental treatment and more susceptible to its toxicities.)
* Seronegativo para el antígeno de la hepatitis B, y seronegativo para el anticuerpo de la hepatitis C. Si la prueba de anticuerpos de la hepatitis C es positiva, el paciente debe someterse a una prueba de detección del antígeno mediante RT-PCR y ser negativo para el ARN del VHC.
* Hematology

* ANC greater than 1000/mm^3 without the support of filgrastim
* WBC mayor o igual a 2500/mm^3
* Recuento de plaquetas mayor o igual a 80.000/mm^3
* Hemoglobina > 8,0 g/dL. Los sujetos pueden ser transfundidos para alcanzar este límite.
* Chemistry

* Serum ALT/AST less than or equal to 5.0 times 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 less than 3.0 mg/dL.
* Patients must have either an eGFR > 60 mL/m (based on serum creatinine and lab nomogram) or a formal 6-24h CrCl > 60 mL/m.
* Patients must have completed any prior systemic therapy at the time of enrollment.

Nota: Los pacientes pueden haber sido sometidos a intervenciones quirúrgicas menores o a radioterapia de campo limitado en las cuatro semanas previas a la inscripción, siempre que las toxicidades orgánicas importantes relacionadas se hayan recuperado hasta un grado inferior o igual a 1.

* Ability of subject to understand and the willingness to sign a written informed consent document.
* Willing to sign a durable power of attorney.
* Subjects must be co-enrolled on protocol 03C0277.

Criterios de exclusión

CRITERIOS DE EXCLUSIÓN:

* Large volume pulmonary irradiation.
* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
* Terapia esteroidea sistémica concurrente.
* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
* Cualquier forma de inmunodeficiencia primaria (como la enfermedad de inmunodeficiencia combinada grave).
* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
* Antecedentes de reacción de hipersensibilidad inmediata grave a la ciclofosfamida, fludarabina o aldesleukina.
* 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%.
* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% or DLCO less than 60%.
* Patients who are receiving any other investigational agents.