Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Phase 1CompletedNCT02071537

University of Cincinnati24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Neoplasm Solid Tumors

Interventions

ChloroquineDRUG

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.

CarboplatinDRUG

Administered day 1 of each 21 day cycle for 4-6 cycles.

GemcitabineDRUG

Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine

Time frame: Up to 12 months

Secondary Outcomes

Time to Disease Progression

Time frame: Up to 24 months

Time of Overall Survival

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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