Malignant NeoplasmPhase 1NCT02071537
Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
A Phase 1 study testing Chloroquine, Carboplatin and Gemcitabine in people with Malignant Neoplasm and Solid Tumors, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Solid Tumors
- What is being tested?
- Chloroquine, Carboplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2014to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267-0502
About this study
Official title: A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
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
- Being tested
- Chloroquine, Carboplatin, Gemcitabine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called Chloroquine Phosphate, Aralen
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
Also called Paraplatin, CBDCA
Administered day 1 of each 21 day cycle for 4-6 cycles.
GemcitabineDrug
Also called Gemzar
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine with Carboplatin/Gemcitabine | Experimental | Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating. Receives: Drug: Chloroquine; Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
Measured: Up to 12 months
Secondary outcomes (2)
Time to Disease Progression
Measured: Up to 24 months
Time of Overall Survival
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start13 May 2014
- Primary completion3 Mar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagla Abdel-Karim, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071537
- Sponsor's protocol ID
- UCCI-EXP-13-01
- Status last verified
- Nov 2019
- First submitted
- 19 Feb 2014
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02071537
- Acronym / sponsor ID
- UCCI-EXP-13-01
- Conditions
- Malignant Neoplasm, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 13 May 2014 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chloroquine with Carboplatin/Gemcitabine | Experimental | Drug: Chloroquine, Drug: Carboplatin, Drug: GemcitabineChloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: Chloroquine Phosphate, AralenDose 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. | Drug | Chloroquine with Carboplatin/Gemcitabine |
| CarboplatinAlso: Paraplatin, CBDCAAdministered day 1 of each 21 day cycle for 4-6 cycles. | Drug | Chloroquine with Carboplatin/Gemcitabine |
| GemcitabineAlso: GemzarAdministered days 1 and 8 of each 21 day cycle for 4-6 cycles. | Drug | Chloroquine with Carboplatin/Gemcitabine |
Primary outcome
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
Time frame: Up to 12 months
2 secondary outcomes
Time to Disease Progression
Time frame: Up to 24 months
Time of Overall Survival
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagla Abdel-Karim, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chloroquine, Carboplatin and Gemcitabine in people with Malignant Neoplasm and Solid Tumors, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.