Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors (GEMINI)
22. juni 2026 oppdatert av: Sarcoma Oncology Research Center, LLC
GEMINI: Phase II Study Using Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors
This is an open label phase II study using metronomic low-dose gemcitabine and mitomycin c given intravenously, and thalidomide administered orally, for patients with advanced solid tumors.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This Phase II open-label single-site study will evaluate the safety and efficacy of metronomic low dose (MLD) therapy with gemcitabine, mitomycin c, and thalidomide in approximately 40-60 patients with pathologically confirmed advanced solid tumors.
Patients will receive gemcitabine 600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15; Mitomycin C 14 mg i.v.
every 6 weeks; and Thalidomide 100 mg p.o. daily x 15 days.
CT scan or MRI will be done every 6 weeks for 6 months and every 12 weeks thereafter until disease progression or unacceptable toxicity up to one year of treatment.
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Victoria Chua-Alcala, MD
- Telefonnummer: 3105529999
- E-post: vchua@sarcomaoncology.com
Studer Kontakt Backup
- Navn: Erlinda M. Gordon, MD
- Telefonnummer: 3105529999
- E-post: egordon@sarcomaoncology.com
Studiesteder
-
-
California
-
Santa Monica, California, Forente stater, 90403
- Rekruttering
- Sarcoma Oncology Research Center / Cancer Center of Southern California
-
Ta kontakt med:
- Victoria Chua-Alcala, MD
- Telefonnummer: 3105529999
- E-post: vchua@sarcomaoncology.com
-
Underetterforsker:
- Ania Moradkhani, NP
-
Ta kontakt med:
- Erlinda M. Gordon, MD
- Telefonnummer: 3105529999
- E-post: egordon@sarcomaoncology.com
-
Underetterforsker:
- Sant P. Chawla, MD
-
Underetterforsker:
- Erlinda M. Gordon, MD
-
Underetterforsker:
- Doris Quon, MD, PhD
-
Underetterforsker:
- Steven G. Wong, MD
-
Underetterforsker:
- Ted Kim, PA
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced or metastatic solid tumor
- Previously treated participants
- Measurable disease by RECIST v1.1
- ECOG performance status ≤ 1
- Life expectancy of at least 3 months
- Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (< 5 x ULN if liver metastases); Acceptable renal function: Creatinine < 1.5 times ULN
- Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC ≥ 1500 cells/μL; Platelet count ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL; Normal PT, PTT, INR
- All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.
- Females of reproductive potential must have 2 negative pregnancy tests before initiating THALOMID. The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing THALOMID. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. THALOMIDE treatment must be discontinued during this evaluation.
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
- Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.
- Subjects with carcinomatous meningitis
- Subjects who participated in an investigational drug or device study within 14 days prior to study entry
- Subjects who had chemotherapy within 14 days prior to study entry
- Females who are pregnant or breast-feeding
- Unwillingness or inability to comply with the study protocol for any reason
- Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Single Arm
Gemcitabine 600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15; Mitomycin C 14 mg i.v.
every 6 weeks; Thalidomide 100 mg p.o. daily x 15 days
|
600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15
Mitomycin C 14 mg i.v.
every 6 weeks
Thalidomide 100 mg daily x 15 days
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: 12 months
|
Progression free survival up to disease progression or death from any cause
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR)
Tidsramme: 12 months
|
Percentage of patients who achieve either a Complete Response (CR) or a Partial Response (PR)
|
12 months
|
|
Progression Free Survival at 6 and 12 months
Tidsramme: 6 months; 12 months
|
Percentage of patients progression free at 6 and 12 months
|
6 months; 12 months
|
|
Overall Survival at 6, 12, 24 months
Tidsramme: 6 months; 12 months; 24 months
|
Percentage of patients surviving at 6, 12, and 24 months
|
6 months; 12 months; 24 months
|
|
Adverse Events
Tidsramme: 12 months
|
The incidence and severity of adverse events
|
12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Neal S. Chawla, MD, Sarcoma Oncology Research Center, LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Chen H, Wu S, Tang M, Zhao R, Zhang Q, Dai Z, Gao Y, Yang S, Li Z, Du Y, Yang A, Zhong L, Lu L, Xu L, Shen X, Liu S, Zhong J, Li X, Lu H, Xiong H, Shen Y, Chen H, Gong S, Xue H, Ge Z. Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia. N Engl J Med. 2023 Nov 2;389(18):1649-1659. doi: 10.1056/NEJMoa2303706.
- Shen Y, Li S, Wang X, Wang M, Tian Q, Yang J, Wang J, Wang B, Liu P, Yang J. Tumor vasculature remolding by thalidomide increases delivery and efficacy of cisplatin. J Exp Clin Cancer Res. 2019 Oct 28;38(1):427. doi: 10.1186/s13046-019-1366-x.
- Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53(282 (Jun 1958)):457-81.
- Isacoff W.H., Chawla NS, Sekhon S, Bhuiyan I, Monick E, Jeffrey S, Gordon EM. Treatment of Elderly Patients with Advanced Pancreatic Ductal Adenocarcinoma Utilizing a Metronomic Dose and Schedule of Chemotherapy: A Better Approach. Cancers 2025 Preprint doi:10.20944/preprints202510.0364.v1
- Isacoff WH, Cooper B, Bartlett A, McCarthy B, Yu KH. ChemoSensitivity Assay Guided Metronomic Chemotherapy Is Safe and Effective for Treating Advanced Pancreatic Cancer. Cancers (Basel). 2022 Jun 13;14(12):2906. doi: 10.3390/cancers14122906.
- Liu Q, Chiang ZC, Zhao X, Cui D, Li X, Chen H, Lin F, Jiang T, Chen Q, Lin X, Lin J. Strengthening Effect of Thalidomide Combined with an Anti-PD1 Antibody on Enhancing Immunity for Lung Cancer Therapy. Curr Pharm Biotechnol. 2025;26(17):2724-2737. doi: 10.2174/0113892010319495241218114812.
- Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics. 1982;38:29-41.
- Ballon J, Savage PA, Agarwal AD, Jeffrey S, Syed S, et al. A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, and Docetaxel Plus Nivolumab Advanced Leiomyosarcoma and Liposarcoma (NCT04535713). J Clin 1ncol 1515, 2025
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. juni 2029
Datoer for studieregistrering
Først innsendt
22. juni 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Karboksylsyrer
- Piperidines
- Indoler
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Kinoner
- Aziriner
- Ftalimider
- Ftalsyrer
- Syrer, karbosykliske
- Piperidoner
- Isoindoles
- Mitomycins
- Indolekinoner
- Gemcitabin
- Thalidomid
- Mitomycin
Andre studie-ID-numre
- SOC-2602
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .