Clinical trial · Interventional
Interleukin-7 in Treating Patients With Metastatic Melanoma or Locally Advanced or Metastatic Kidney Cancer
A Phase I Study of Subcutaneous "CYT 107" (Interleukin-7) in Refractory Metastatic Melanoma or Renal Cell Carcinoma
NCT00492440CI-TRIAL-00008289terminatedPhase 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-7 may stimulate the white blood cells to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| recombinant interleukin-7 |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CYT107 (r-hIL-7)
- interventionNames
- Biological: recombinant interleukin-7
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: protein expression analysis
- Other: flow cytometry
- Other: immunoenzyme technique
- Other: immunologic technique
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Safety of recombinant interleukin-7 (IL-7)
Secondary outcomes (4)
- measure
- Pharmacokinetics and pharmacodynamics of IL-7
- measure
- Comparison of the biological and clinical effects of recombinant IL-7 with non glycosylated IL-7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Melanoma
* Metastatic disease
* Renal cell carcinoma
* Locally advanced and unresectable disease OR metastatic disease
* Refractory to standard therapy OR ineligible to receive standard therapy
* Measurable or evaluable disease
* Previously received high-dose interleukin-2 OR have a contraindication for this treatment
* No previously untreated or unstable brain metastases
* No splenic metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* PT/PTT ≤ 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* AST and ALT \< 2.5 times ULN
* Conjugated (Direct) bilirubin ≤ 1.25 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria:
* History of ECG abnormalities
* Symptoms of cardiac ischemia
* At least 50 years of age and over
* Familial or personal history of heart failure
* Previously treated with antimitotic agents susceptible to trigger heart failure
* FEV\_1 \> 60% of predicted (for patients with a prolonged smoking history or symptoms of respiratory dysfunction)
* No concurrent cognitive impairment or likelihood of developing cognitive impairment on study therapy
* No concurrent splenomegaly or proliferative hematologic disease
* No documented HIV positivity
* No acute hepatitis A or hepatitis B or C
* Positive hepatitis B serology indicative of previous immunization (i.e., HBs Ab positive and HBc Ab negative) allowed
* Positive hepatitis C serology allowed provided HCV RNA load by PCR is negative
* Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy
* Untreated hypertensive patients who received standard antihypertensive therapy allowed provided hypertension is well controlled
* No QTc prolongation ≥ 470 msec
* No prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities
* No active infection requiring systemic treatment and/or hospitalization within the past 28 days
* Patients who have completed therapy or are clinically stable on therapy, in the opinion of the investigator, are eligible
* No history of autoimmune disease
* No history of severe asthma
* No history of medical or psychiatric disease that would preclude study treatment
* No documented cirrhosis or documented acute hepatitis
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior systemic corticosteroid therapy
* More than 4 weeks since prior and no other concurrent cytotoxic therapy, immunotherapy, biological agents (i.e., cytokines, growth factors, or monoclonal antibodies), or antitumor vaccines
* More than 7 days since prior hepatotoxic drugs unless medically necessary
* More than 2 days since prior alcohol consumption
* More than 1 day since prior acetaminophen use
* No prior splenectomy
* No prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
* No concurrent palliative therapy
* No concurrent chemotherapy
* No concurrent chronic anticoagulation (i.e., high-dose warfarin or heparin)
* Warfarin dose 1 to 2 mg/day allowed
* No concurrent chronic medications for asthma
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.