Lymphoma, T-CellPhase 2NCT00038376
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
A Phase 2 study testing Isotretinoin (Accutane) and Interferon Alpha in people with Lymphoma, T-Cell and Mycosis Fungoides, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Mycosis Fungoides, Hematologic Neoplasms
- What is being tested?
- Isotretinoin (Accutane) and Interferon Alpha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 1990to 30 Jun 2005
- Phase
- Phase 2
- 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
- Patients with histologic proof of incurable T-cell malignancy or Hodgkin's disease, and not eligible for existing/higher priority protocols. Patients with Hodgkin's disease will be eligible only if they have failed at least a MOPP-like and ABVD-like regimen.
- Patients should not have received chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within three weeks of entry into the study and must have recovered from acute toxic effects of prior therapy.
- Patients must have a life expectancy of at least 12 weeks and a performance status of less than or equal to 2 (Zubrod scale: Appendix A).
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with policies of the hospital. The only approved consent form is appended to this protocol.
- Patients must have measurable or evaluable disease.
- Patients must be greater than or equal to 18 years old.
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- Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
- Patients should have adequate hepatic function with bilirubin of less than or equal to 2.0 mg%, and SGPT of less than or equal to 4 times the upper limits of normal.
- Patients should have adequate renal function (defined as serum creatinine of less than or equal to 2.0 mg%).
- Patients should have serum triglyceride level less than or equal to 2.5 times the upper limits of normal.
- Patients may not have serious intercurrent medical illness.
- Patients of child bearing potential must be practicing adequate contraception.
- Patients will be eligible regardless of the extent of prior chemotherapy.
Who cannot join
- 1) Pediatric Patients under 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane).
Read the detailed description
Retinoids have shown activity in T-cell malignancies in past studies (both isotretinoin and etretinate) with an overall response rate of about 60%. One third of those responses were complete responses. Interferon-alpha has proven efficacy in wide ranges of human malignancies including T-cell lymphomas as a single agent. A clinical trial was needed to evaluate the response rate of these two agents combined.
Interferon is a normal body protein, which is made by cells after exposure to viruses. It acts as a messenger to warn surrounding cells of invasions by viruses and, possibly, by cancer cells. Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells.
Participants participating in this study will receive a combination of alpha-interferon and isotretinoin. Alpha-interferon will be given once a day for an initial period of 12 weeks. Participants will take the drug home, where a nurse or family member of the participant (who can be trained at UTMDACC) will inject it just under the skin (SQ). Isotretinoin will be given by mouth twice a day.
If a participant's disease does not show a response, the alpha-interferon and the isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be discontinued. If the participant's disease is unresponsive or worsens, the participant will be taken off study and other treatments will be recommended.
Responding participants will be placed on a maintenance schedule for as long as they respond. Up to 60 participants will be studied at UT M.D. Anderson Cancer Center to test the effectiveness of this drug combination.
This is an investigational study. Alpha-interferon and isotretinoin are FDA approved and commercially available.
- Conditions
- Lymphoma, T-Cell, Mycosis Fungoides, Hematologic Neoplasms
- Being tested
- Isotretinoin (Accutane), Interferon Alpha
- Keywords
- T-cell lymphoma, accutane, isotretinoin, mycosis fungoides, T-cell malignancies
- Medical subject headings
- Lymphoma, T-Cell, Mycosis Fungoides, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin (Accutane)Drug
Also called 13-cis-Retinoic Acid
0.5 mg/k (1.0 mg/k total) by mouth twice a day
Interferon AlphaDrug
Also called Intron A, Interferon alfa-2b
Starting dose of 3 MU injected under skin once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Alpha-interferon + Isotretinoin Receives: Drug: Isotretinoin (Accutane); Drug: Interferon Alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2002 (estimated)
- Study start8 May 1990
- Primary completion30 Jun 2005
- Study completion30 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Razelle Kurzrock, MD, BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038376
- Sponsor's protocol ID
- DM90-007
- Status last verified
- Oct 2018
- First submitted
- 30 May 2002
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
- ClinicalTrials.gov ID
- NCT00038376
- Acronym / sponsor ID
- DM90-007
- Conditions
- Lymphoma, T-Cell, Mycosis Fungoides, Hematologic Neoplasms
- Keywords
- T-cell lymphoma, accutane, isotretinoin, mycosis fungoides, T-cell malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 May 1990 (actual)
- Primary completion
- 30 Jun 2005 (actual)
- Study completion
- 30 Jun 2005 (actual)
- First posted
- 31 May 2002 (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 study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane).
Detailed description
Retinoids have shown activity in T-cell malignancies in past studies (both isotretinoin and etretinate) with an overall response rate of about 60%. One third of those responses were complete responses. Interferon-alpha has proven efficacy in wide ranges of human malignancies including T-cell lymphomas as a single agent. A clinical trial was needed to evaluate the response rate of these two agents combined.
Interferon is a normal body protein, which is made by cells after exposure to viruses. It acts as a messenger to warn surrounding cells of invasions by viruses and, possibly, by cancer cells. Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells.
Participants participating in this study will receive a combination of alpha-interferon and isotretinoin. Alpha-interferon will be given once a day for an initial period of 12 weeks. Participants will take the drug home, where a nurse or family member of the participant (who can be trained at UTMDACC) will inject it just under the skin (SQ). Isotretinoin will be given by mouth twice a day.
If a participant's disease does not show a response, the alpha-interferon and the isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be discontinued. If the participant's disease is unresponsive or worsens, the participant will be taken off study and other treatments will be recommended.
Responding participants will be placed on a maintenance schedule for as long as they respond. Up to 60 participants will be studied at UT M.D. Anderson Cancer Center to test the effectiveness of this drug combination.
This is an investigational study. Alpha-interferon and isotretinoin are FDA approved and commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Isotretinoin (Accutane), Drug: Interferon AlphaAlpha-interferon + Isotretinoin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with histologic proof of incurable T-cell malignancy or Hodgkin's disease, and not eligible for existing/higher priority protocols. Patients with Hodgkin's disease will be eligible only if they have failed at least a MOPP-like and ABVD-like regimen.
- Patients should not have received chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within three weeks of entry into the study and must have recovered from acute toxic effects of prior therapy.
- Patients must have a life expectancy of at least 12 weeks and a performance status of less than or equal to 2 (Zubrod scale: Appendix A).
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with policies of the hospital. The only approved consent form is appended to this protocol.
- Patients must have measurable or evaluable disease.
Key exclusion criteria (1 listed)
- 1) Pediatric Patients under 18 years old.
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 |
|---|---|---|
| Isotretinoin (Accutane)Also: 13-cis-Retinoic Acid0.5 mg/k (1.0 mg/k total) by mouth twice a day | Drug | 1 |
| Interferon AlphaAlso: Intron A, Interferon alfa-2bStarting dose of 3 MU injected under skin once a day for 12 weeks. | Drug | 1 |
Primary outcome
To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.
Time frame: 15 Years
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 29 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Razelle Kurzrock, MD, BS principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isotretinoin (Accutane) and Interferon Alpha in people with Lymphoma, T-Cell and Mycosis Fungoides, run by M.D. Anderson Cancer 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 13 inclusion and 1 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 29 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies. (time frame: 15 Years). 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 29 Oct 2018.