Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
NCT ID: NCT02071537
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-05-13
2018-12-31
Brief Summary
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Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
Chloroquine
Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.
Carboplatin
Administered day 1 of each 21 day cycle for 4-6 cycles.
Gemcitabine
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
Interventions
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Chloroquine
Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.
Carboplatin
Administered day 1 of each 21 day cycle for 4-6 cycles.
Gemcitabine
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>18 years of age.
* Performance status less than or equal 2 (Karnofsky \>60%)
* Life expectancy of greater than 3 months.
* Adequate labs
* Measurable disease
Exclusion Criteria
* Patients with untreated brain metastases
* History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Nagla Abdel-Karim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCCI-EXP-13-01
Identifier Type: -
Identifier Source: org_study_id
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