Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

NCT02071537 | Completed Phase 1 DMC

• 1 other identifier: UCCI-EXP-13-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine

  Up to 12 months

Secondary Outcomes (2)

• Time to Disease Progression

  Up to 24 months

• Time of Overall Survival

  Up to 24 months

Study Arms (1)

Chloroquine with Carboplatin/Gemcitabine

EXPERIMENTAL

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

Drug: Chloroquine; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Chloroquine DRUG

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.

Also known as: Chloroquine Phosphate, Aralen

Chloroquine with Carboplatin/Gemcitabine

Carboplatin DRUG

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

Also known as: Paraplatin, CBDCA

Chloroquine with Carboplatin/Gemcitabine

Gemcitabine DRUG

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

Also known as: Gemzar

Chloroquine with Carboplatin/Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267-0502, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Chloroquine; chloroquine diphosphate; Carboplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nagla Abdel-Karim, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 26, 2014
• Study Start: May 13, 2014
• Primary Completion: March 3, 2018
• Study Completion: December 1, 2018
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)