Health TrialsbyHealthPanel

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

ConditionSolid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarcoma Oncology Research Center, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Gemcitabine

    Drug

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

  • Mitomycin C

    Drug

    Mitomycin C 14 mg i.v. every 6 weeks

  • Thalidomide

    Drug

    Thalidomide 100 mg daily x 15 days

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

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

Time frame
12 months

Secondary outcomes

1

Objective Response Rate (ORR)

Percentage of patients who achieve either a Complete Response (CR) or a Partial Response (PR)

Time frame
12 months
2

Progression Free Survival at 6 and 12 months

Percentage of patients progression free at 6 and 12 months

Time frame
6 months; 12 months
3

Overall Survival at 6, 12, 24 months

Percentage of patients surviving at 6, 12, and 24 months

Time frame
6 months; 12 months; 24 months
4

Adverse Events

The incidence and severity of adverse events

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sarcoma Oncology Research Center, LLC

Lead sponsor

Source ClinicalTrials.gov
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