Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Condition(s) targeted: Malignant Neoplasm; Solid Tumors

Intervention: Chloroquine (Drug); Carboplatin (Drug); Gemcitabine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Nagla Abdel-Karim, MD, Principal Investigator, Affiliation: University of Cincinnati

Overall contact:
UC Cancer Institute Clinical Trials Office, Phone: 513-584-7698, Email: kastla@ucmail.uc.edu

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine

Secondary outcome:

Time to Disease Progression

Time of Overall Survival

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

UC Cancer Institute Clinical Trials Office, Phone: 513-584-7698, Email: kastla@ucmail.uc.edu

University of Cincinnati Cancer Institute, Cincinnati, Ohio 45267-0502, United States; Recruiting
Nagla Karim, MD, PhD, Principal Investigator
Johm Morris, MD, Sub-Investigator
Sadia Benzaquin, MD, Sub-Investigator
Pankaj Desai, MS, PhD, Sub-Investigator
James Driscol, MD, Sub-Investigator
Ahmed Khaled, MD, Sub-Investigator
Jun Ying, PhD, Sub-Investigator

Starting date: May 2014
Last updated: December 12, 2014