Lymphoma, T-Cell, CutaneousEarly Phase 1NCT03116659
CTCL Directed Therapy
A Early Phase 1 study testing Doxycycline and Imiquimod in people with Lymphoma, T-Cell, Cutaneous, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Read more about this study
- Who is it for?
- Ages 30 to 89 years
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- Doxycycline and Imiquimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Dec 2020
- Phase
- Early 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 30 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 30 - 89 years old
- Stages I to II CTCL patients
- Normal renal function, Cr ≤ 1.5
Who cannot join
- Aggressively progressing CTCL
- Active infection and/or concurrent malignancy
- Poor renal function (Cr > 1.5)
- Pregnancy (HCG serum +)
- History of bone marrow suppression, MDS, anemia (Hemoglobin < 8), thrombocytopenia (< 50,000) or neutropenia (ANC < 1500)
- CHF, MI within last 6 months
- Endocarditis
- Allergies to Imiquimod or doxycycline
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J Peters Bronx Veterans Affairs Medical Center
The Bronx, New York, 10468
Ali Dana, MD/PhD
About this study
Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL is made by several years. Early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis.
Inflammation secondary to bacterial infection is thought to contribute to the T-cell proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in CTCL patients. There has been limited studies with the use of antibiotics as direct treatment for this cancer.
Read more
Host immunity is important in decreasing cancer development and progression. Imiquimod is a molecule that stimulates host immunity to reduce the progression of CTCL. There is strong evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN) guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it unlikely to be registered specifically for CTCL, despite its efficacy.
Additionally, imiquimod is considered a first line treatment according to National Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.
There are currently no studies that have been published that address treating CTCL patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat patient with 14days of antibiotics and 30 days of Imiquimod there will be significant reduction in skin lesions.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- Doxycycline, Imiquimod
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 100 mg PO BID x 14 days
ImiquimodDrug
up to 2 packs 3/ week x 28 days
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days Receives: Drug: Doxycycline; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot assessment of response.
Pilot assessment of response assessed by decreased size or surface change of the 5 lesions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Feb 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ali Dana, James J. Peters Veterans Affairs Medical Center
- Investigators
- Ali Dana, MD, Principal investigator, James J. Peters VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116659
- Sponsor's protocol ID
- DAN-15-028
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Guzzo CA, Kojadinovic A, Vinnakota RR, Geskin LJ, Newman JC, Langhoff E, Park YA, Bates SE, Dana AN. Antibiotics and Imiquimod for Cutaneous T-Cell Lymphoma in Veterans: A Patient Population with Agent Orange Exposure. Oncologist. 2021 Sep;26(9):727-e1488. doi: 10.1002/onco.13785. Epub 2021 May 14.
PubMed 33851477
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTCL Directed Therapy
- ClinicalTrials.gov ID
- NCT03116659
- Acronym / sponsor ID
- DAN-15-028
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Apr 2017 (actual)
- 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.
Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL is made by several years. Early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis.
Inflammation secondary to bacterial infection is thought to contribute to the T-cell proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in CTCL patients. There has been limited studies with the use of antibiotics as direct treatment for this cancer.
Host immunity is important in decreasing cancer development and progression. Imiquimod is a molecule that stimulates host immunity to reduce the progression of CTCL. There is strong evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN) guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it unlikely to be registered specifically for CTCL, despite its efficacy.
Additionally, imiquimod is considered a first line treatment according to National Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.
There are currently no studies that have been published that address treating CTCL patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat patient with 14days of antibiotics and 30 days of Imiquimod there will be significant reduction in skin lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Doxycycline, Drug: ImiquimodDoxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 30 - 89 years old
- Stages I to II CTCL patients
- Normal renal function, Cr ≤ 1.5
Key exclusion criteria (8 listed)
- Aggressively progressing CTCL
- Active infection and/or concurrent malignancy
- Poor renal function (Cr > 1.5)
- Pregnancy (HCG serum +)
- History of bone marrow suppression, MDS, anemia (Hemoglobin < 8), thrombocytopenia (< 50,000) or neutropenia (ANC < 1500)
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 |
|---|---|---|
| DoxycyclineDoxycycline 100 mg PO BID x 14 days | Drug | Single Arm |
| Imiquimodup to 2 packs 3/ week x 28 days | Drug | Single Arm |
Primary outcome
Pilot assessment of response.
Time frame: 1 year
Pilot assessment of response assessed by decreased size or surface change of the 5 lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 33851477Del Guzzo CA, Kojadinovic A, Vinnakota RR, Geskin LJ, Newman JC, Langhoff E, Park YA, Bates SE, Dana AN. Antibiotics and Imiquimod for Cutaneous T-Cell Lymphoma in Veterans: A Patient Population with Agent Orange Exposure. Oncologist. 2021 Sep;26(9):727-e1488. doi: 10.1002/onco.13785. Epub 2021 May 14.
- Individual participant dataSharing planned: No
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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.
Ali Dana, MD principal investigator
James J. Peters VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Doxycycline and Imiquimod in people with Lymphoma, T-Cell, Cutaneous, run by James J. Peters Veterans Affairs Medical Center 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Dana, MD (718-584-9000 ext. 5289, Ali.Dana@VA.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot assessment of response. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116659, which also lists 1 linked publication.
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 13 Aug 2019.