Clinical trial · Interventional
Interleukin-2 in Treating Patients With Mycosis Fungoides
Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
NCT00002687CI-TRIAL-00008587completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.