LymphomaPhase 2NCT00030849
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
A Phase 2 study testing recombinant interferon alfa and bexarotene in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- recombinant interferon alfa and bexarotene
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Oct 2001to Dec 2009
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell lymphoma
- Stage IB, IIA, IIB, III, or IV
- Measurable or assessable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 9 g/dL
- WBC at least 1,500/mm^3
- Platelet count at least 70,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 3 times ULN
- Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study)
- No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction)
Renal:
- Calcium no greater than 11.5 mg/dL
- Creatinine no greater than 2 times ULN
Cardiovascular:
- No myocardial infarction in the past 6 months
- No unstable angina
- No class III or IV congestive heart failure
- No ventricular tachyarrhythmias
Pulmonary:
- No pulmonary infiltrates or clinical pulmonary impairment
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy
- No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs
- No uncontrolled thyroid disorder
- No other concurrent serious medical illness that would preclude study
- No infection
- No history of pancreatitis
- No history of neuropsychiatric disorders requiring hospitalization
- No history of autoimmune disease that would pose significant risk
- Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent systemic anticancer chemotherapy
Endocrine therapy:
- No concurrent systemic corticosteroids
Radiotherapy:
- No concurrent localized radiotherapy to target lesions unless considered
- to have shown progressive disease
Surgery:
- Not specified
Other:
- At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug
- At least 30 days since prior participation in any other investigational drug study
- No concurrent systemic anti-psoriatic drugs or therapies
- No concurrent systemic other anticancer drugs or therapies
- No concurrent gemfibrozil
- No other concurrent investigational medication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa.
- Determine the safety and toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral bexarotene once daily for 8 weeks.
Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity.
Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.
- Conditions
- Lymphoma
- Being tested
- recombinant interferon alfa, bexarotene
- Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
bexaroteneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionSep 2004
- Study completionDec 2009
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David J. Straus, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030849
- Sponsor's protocol ID
- CDR0000069202
- Other IDs
- MSKCC-01128, NCI-G01-2049
- Status last verified
- Dec 2009
- First submitted
- 14 Feb 2002
- Last updated
- 4 Apr 2013
- Results posted
- No
Publications
Straus DJ, Duvic M, Kuzel T, Horwitz S, Demierre MF, Myskowski P, Steckel S. Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma. Cancer. 2007 May 1;109(9):1799-803. doi: 10.1002/cncr.22596.
PubMed 17366595
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00030849
- Acronym / sponsor ID
- CDR0000069202
- Conditions
- Lymphoma
- Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001
- Primary completion
- Sep 2004 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
Detailed description
OBJECTIVES:
- Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa.
- Determine the safety and toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral bexarotene once daily for 8 weeks.
Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity.
Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| bexarotene | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Apr 2013.
- Results publication: PubMed 17366595Straus DJ, Duvic M, Kuzel T, Horwitz S, Demierre MF, Myskowski P, Steckel S. Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma. Cancer. 2007 May 1;109(9):1799-803. doi: 10.1002/cncr.22596.
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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.
David J. Straus, MD study chair
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa and bexarotene in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 5 sites 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?
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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030849, 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 4 Apr 2013.