ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 158 for:    Chloroquine phosphate

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02071537
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Nagla Karim, University of Cincinnati

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm Solid Tumors Drug: Chloroquine Drug: Carboplatin Drug: Gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
Study Start Date : May 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
Drug: Chloroquine
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.
Other Names:
  • Chloroquine Phosphate
  • Aralen

Drug: Carboplatin
Administered day 1 of each 21 day cycle for 4-6 cycles.
Other Names:
  • Paraplatin
  • CBDCA

Drug: Gemcitabine
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
Other Name: Gemzar




Primary Outcome Measures :
  1. Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: Up to 24 months ]
  2. Time of Overall Survival [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071537


Contacts
Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 kastla@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45267-0502
Principal Investigator: Nagla Karim, MD, PhD         
Sub-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         
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Nagla Abdel-Karim, MD University of Cincinnati

Responsible Party: Nagla Karim, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02071537     History of Changes
Other Study ID Numbers: UCCI-EXP-13-01
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Chloroquine diphosphate
Chloroquine
Neoplasms
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics