Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Conditions
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Malignant Neoplasm, Solid Tumors

Intervention / Treatment
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* Drug: Chloroquine
* Drug: Carboplatin
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine with Carboplatin/Gemcitabine<br>Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating. | Drug: Chloroquine<br>* 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.<br>* Other names: Aralen;Drug: Carboplatin<br>* Administered day 1 of each 21 day cycle for 4-6 cycles.<br>* Other names: CBDCA;Drug: Gemcitabine<br>* Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression |  | Up to 24 months | 
| Time of Overall Survival |  | Up to 24 months |