- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00319748
Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
21. August 2019 aktualisiert von: Masonic Cancer Center, University of Minnesota
Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
15
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- Masonic Cancer Center, University of Minnesota
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
Adequate performance status:
- Breast - Karnofsky score > 50;
- Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2
- If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
- Normal organ function within 14 days of study entry
Diagnosis of one of the following malignancies:
- Metastatic breast cancer (BR)
- Metastatic ovarian cancer (OV)
- Metastatic endometrial cancer (EM)
- Metastatic cervical cancer (CX)
Breast Cancer Inclusion Criteria:
- Measurable metastatic disease (>1cm) in at least one site other than bone-only
- Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease
- Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.
Ovarian Cancer Inclusion Criteria:
- Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).
- Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.
Endometrial Cancer Inclusion Criteria:
- Measurable metastatic disease
- Histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens
Cervical Cancer Inclusion Criteria:
- Measurable metastatic disease
- Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.
Exclusion Criteria:
Had/have the following prior/concurrent therapy:
- Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
- Investigational drugs/agents within 14 days of first dose of 852A
- Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
- Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions
- Radiotherapy within 3 weeks of the first dose of 852A
- Hematopoietic cell transplantation within 4 weeks of first dose of 852A
- Evidence of active infection within 3 days of first dose of 852A
- Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)
- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- Uncontrolled intercurrent or chronic illness
- Active autoimmune disease requiring immunosuppressive therapy within 30 days
- Active coagulation disorder not controlled with medication
- Pregnant or lactating
- Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated
- Any history of brain metastases or any other active central nervous system (CNS) disease
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Intent-To-Treat
Patients treated with at least one dose - 852A subcutaneous injection.
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0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Andere Namen:
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Experimental: Evaluable Cohort
Patients who received all 24 doses of 852A per protocol.
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0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Zeitfenster: after 12 weeks (24 doses of 852A)
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Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses.
Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
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after 12 weeks (24 doses of 852A)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
Zeitfenster: Prior to Dose 1 and 6 hours after Dose 1
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Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 hours after Dose 1
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Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
Zeitfenster: Prior to Dose 1 and 6 Hours Post-Dose
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Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Zeitfenster: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
Zeitfenster: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Soluble CD40 Ligand (sCD40L)
Zeitfenster: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
Zeitfenster: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Sarah Cooley, MD, Masonic Cancer Center, University of Minnesota
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2006
Primärer Abschluss (Tatsächlich)
1. Dezember 2007
Studienabschluss (Tatsächlich)
1. Dezember 2008
Studienanmeldedaten
Zuerst eingereicht
27. April 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. April 2006
Zuerst gepostet (Schätzen)
27. April 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. August 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. August 2019
Zuletzt verifiziert
1. August 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Uterusneoplasmen
- Genitale Neubildungen, weiblich
- Gebärmutterhalskrankheiten
- Uteruserkrankungen
- Erkrankungen des endokrinen Systems
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen der endokrinen Drüse
- Gebärmutterhalstumoren
- Eierstocktumoren
- Endometriale Neubildungen
Andere Studien-ID-Nummern
- 06US03IMP-852A
- MT2006-02 (Andere Kennung: Blood and Bone Marrow Transplantation Program)
- 2006LS005 (Andere Kennung: Masonic Cancer Center, University of Minnesota)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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