- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01896271
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390
- University of Texas Southwestern Medical Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Biopsy-proven metastatic clear cell RCC.
- Radiographic evidence of metastatic disease. 2.1 Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
- Patient must have ≥1 lesion of size >1.5cm.
- Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2
- Age ≥ 18 years.
- Performance status ECOG 0, 1.
- Patient must be eligible for HD IL-2 treatment
- Patient must be eligible for SABR to one or more extra cranial sites.
Adequate organ and marrow function as defined below:
- leukocytes ≥ 3,000/mcL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 50,000/mcl
- total bilirubin ≤ 2mg/dL
- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent
- Adequate Renal function with Cr ≤ 1.6 mg/dL.
- Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test
- Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%).
Exclusion Criteria:
- Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- History of HIV, Hepatitis B, Hepatitis C and HTLV serology
- Subjects may not be receiving any other investigational or standard antineoplastic agents.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis
- Subjects with life expectancy < 6 months.
- History of allergic reactions to recombinant IL-2
- Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days
- Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: treatment
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.
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HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
SABR dose varying from 8Gy-20Gy in 1-3 fractions
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response Rate
Zeitfenster: 6 months
|
Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy
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6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival
Zeitfenster: 4 years
|
Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
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4 years
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Progression Free Survival
Zeitfenster: 4 years
|
Progression Free Survival (PFS), which is defined according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST) as the time between date of registration and the first date of documented disease progression or date of death due to any cause.
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4 years
|
Time to Progression
Zeitfenster: 4 years
|
Time to Progression (TTP), which is defined as time between date of registration and date of documented progression
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4 years
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Local Control Rate
Zeitfenster: 4 years
|
Local recurrence is defined as tumor recurrence within the planning target volume.
Local control rate will be evaluated by imaging techniques such as CT or MRI.
Local recurrence will be defined as an increase of > 20% in tumor size.
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4 years
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Median Response Duration
Zeitfenster: 4 years
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Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression
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4 years
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Tumor-specific Immune Response
Zeitfenster: 4 years
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Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.
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4 years
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Number of Participants With Adverse Events
Zeitfenster: 4 years
|
Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
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4 years
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Health-related Quality of Life (HRQoL).
Zeitfenster: 4 years
|
4 years
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Raquibul Hannan, MD, PhD, University of Texas Southwestern Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU 012013-041
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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