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Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT02071537
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
54.6
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
Actual Study Start Date :
May 13, 2014
Actual Primary Completion Date :
Mar 3, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chloroquine with Carboplatin/Gemcitabine

Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.

Drug: 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.
Other Names:
  • Chloroquine Phosphate
  • Aralen

    • Drug: Carboplatin
    Administered day 1 of each 21 day cycle for 4-6 cycles.
    Other Names:
  • Paraplatin
  • CBDCA

    • Drug: Gemcitabine
    Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
    Other Names:
  • Gemzar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine [Up to 12 months]

    Secondary Outcome Measures

    1. Time to Disease Progression [Up to 24 months]

    2. Time of Overall Survival [Up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy.

    • 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:

    • Current treatment with any other investigational agents.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Cancer Institute Cincinnati Ohio United States 45267-0502

    Sponsors and Collaborators

    • University of Cincinnati

    Investigators

    • Principal Investigator: Nagla Abdel-Karim, MD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02071537
    Other Study ID Numbers:
    • UCCI-EXP-13-01
    First Posted:
    Feb 26, 2014
    Last Update Posted:
    Nov 25, 2019
    Last Verified:
    Nov 1, 2019
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine
    Chloroquine
    Chloroquine diphosphate
    Carboplatin

    Study Results

    No Results Posted as of Nov 25, 2019