Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors

NCT07671534 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SOC-2602
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival up to disease progression or death from any cause

  12 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  12 months

• Progression Free Survival at 6 and 12 months

  6 months; 12 months

• Overall Survival at 6, 12, 24 months

  6 months; 12 months; 24 months

• Adverse Events

  12 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Gemcitabine; Drug: Mitomycin C; Drug: Thalidomide

Interventions

Gemcitabine DRUG

600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15

Single Arm

Mitomycin C DRUG

Mitomycin C 14 mg i.v. every 6 weeks

Single Arm

Thalidomide DRUG

Thalidomide 100 mg daily x 15 days

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sarcoma Oncology Research Center, LLC: lead

Study Sites (1)

Sarcoma Oncology Research Center / Cancer Center of Southern California

Santa Monica, California, 90403, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 31656203 BACKGROUND

• Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53(282 (Jun 1958)):457-81.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35740571 BACKGROUND

• 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.

  PMID: 19097774 BACKGROUND

• 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.

  PMID: 39773053 BACKGROUND

• 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.

  PMID: 37913505 BACKGROUND

• Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics. 1982;38:29-41.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Interventions

Gemcitabine; Mitomycin; Thalidomide

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles

Study Officials

• Neal S. Chawla, MD

  Sarcoma Oncology Research Center, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erlinda M. Gordon, MD

CONTACT

3105529999; egordon@sarcomaoncology.com

Victoria Chua-Alcala, MD

CONTACT

3105529999; vchua@sarcomaoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, phase II study using metronomic low doses of gemcitabine, mitomycin C and thalidomide.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)