Clinical trial · Interventional
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma
- 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: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. Giving genistein together with interleukin-2 may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genistein | Dietary Supplement | — | UNRESOLVED |
| High-dose interleukin-2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genistein and Interleukin-2
- interventionNames
- Biological: High-dose interleukin-2
- Dietary Supplement: genistein
Primary outcomes (1)
- measure
- Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)
- timeFrame
- Days 1, 8, 10, 15, 22, and 24 of treatment
Secondary outcomes (1)
- measure
- Circulating plasma levels of TGF-beta
- timeFrame
- Prior to and at end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Documented histologically confirmed malignant melanoma or renal clear cell carcinoma
* Metastatic disease
* At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter \> 20 mm using conventional techniques OR \> 10 mm with spiral CT scan
* If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
* Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
* The following are considered non-measurable lesions:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Cystic lesions
* Abdominal masses that are not confirmed and followed by imaging techniques
* No CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
* ECOG performance status \< 2
* Life expectancy ≥ 4 months
* Serum creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
* Bilirubin normal
* Platelets \> 100,000/mm³
* WBC \> 3,500/mm³
* No evidence of congestive heart failure
* No symptom of coronary artery disease
* No serious cardiac arrhythmias
* A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
* Adequate pulmonary reserve
* FEV\_1 \> 75% of predicted
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* No known HIV-positive patients
* No evidence of active infection requiring antibiotic therapy
* No contraindication to treatment with pressor agents
* No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study
* No history of another malignancy other than basal cell skin cancer within 5 years
PRIOR CONCURRENT THERAPY:
* Recovered from all toxic effects of prior therapy
* No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment
* No systemic corticosteroids in the 4 weeks prior to treatment
* No previous investigational agent within 4 weeks prior to the start of the study
* No prior interleukin-2 therapy
* No organ allografts allowed
* No concurrent radiotherapy, chemotherapy, or immunotherapy
* No concurrent corticosteroids
* No concurrent chronic medication for asthmaReferences
Publications (0)
Data not yet available