Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

University of Cincinnati

Status and phase

Completed

Phase 1

Conditions

Malignant Neoplasm

Solid Tumors

Treatments

Drug: Carboplatin

Drug: Chloroquine

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02071537

UCCI-EXP-13-01

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.