LymphomaPhase 1NCT00002687
Interleukin-2 in Treating Patients With Mycosis Fungoides
A Phase 1 study testing aldesleukin in people with Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- aldesleukin
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1995to Jul 2003
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinically and histologically proven diagnosis of 1 of the following:
- Mycosis fungoides (MF) meeting 1 of the following conditions:
- Stage IIB disease that has failed psoralen ultraviolet A (PUVA) light therapy and topical chemotherapy (mechlorethamine and/or carmustine)
- Stage III disease with generalized erythroderma
- Stage IV disease with biopsy proven nodal or visceral involvement
- Sezary syndrome
- Stage III MF with a minimum of 20% Sezary cells (based on total WBC)
- No clinically significant ascites or pleural effusion
- Clinically significant pleural effusion defined as shortness of breath with oxygen saturation less than 90%
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 16 weeks
Hematopoietic:
- See Disease Characteristics
- WBC at least 3,500/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 11.5 g/dL
Hepatic:
- Bilirubin less than 2.5 times normal
- SGOT less than 2.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- No nephrotic syndrome
Cardiovascular:
- No history of myocardial infarction or congestive heart failure
- No symptomatic coronary artery disease
- No clinically manifest hypotension
- No severe hypertension
- No arrhythmia on electrocardiogram
- No edema
- No contraindication to pressor agents
Pulmonary:
- See Disease Characteristics
- No dyspnea at rest or severe exertional dyspnea
Neurologic:
- No significant CNS dysfunction, including any of the following:
- Seizure disorder
- Active cerebrovascular disease
- Dementia or delirium
Other:
- No autoimmune disease, including psoriasis
- No uncontrolled peptic ulcer disease
- No uncontrolled infection
- No history of adverse reaction to interleukin-2
- HIV and HTLV-I negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior systemic or topical chemotherapy (6 weeks since prior mitomycin or nitrosoureas)
Endocrine therapy:
- At least 1 week since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- No prior organ allograft
- At least 3 weeks since other prior major surgery
Other:
- At least 4 weeks since prior immunosuppressive therapy
- At least 2 weeks since prior phototherapy (ultraviolet B [UVB] or PUVA light therapy)
- No concurrent phototherapy (UVB or PUVA light therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
Official title: Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides.
- Determine the response rate of patients treated with this regimen.
- Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients.
OUTLINE: This is a dose escalation study.
Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD.
Patients are followed at least 3 times during year 1 and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- aldesleukin
- Keywords
- 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, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
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 startFeb 1995
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A. Thompson, MD, Study chair, Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002687
- Sponsor's protocol ID
- CDR0000064412
- Other IDs
- UW-24218-A/E, NCI-V95-0758
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
- ClinicalTrials.gov ID
- NCT00002687
- Acronym / sponsor ID
- CDR0000064412
- Conditions
- Lymphoma
- Keywords
- 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, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Feb 1995
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (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: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides.
- Determine the response rate of patients treated with this regimen.
- Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients.
OUTLINE: This is a dose escalation study.
Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD.
Patients are followed at least 3 times during year 1 and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 80 years
- 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 |
|---|---|---|
| aldesleukin | Biological | – |
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 Dec 2012.
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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.
John A. Thompson, MD study chair
Seattle Cancer Care Alliance
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 aldesleukin in people with Lymphoma, run by University of Washington 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?
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 Dec 2012. 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.
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 4 Dec 2012.