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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

Phase 0
18 Years
Open (Enrolling)
Kidney Cancer, Melanoma (Skin)

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Trial Information

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



- Measure the differences in peak and duration of the expansion of circulating
CD4-positive, CD8-positive, and CD4-, CD25-, and CD56-positive cells (dim and bright)
at different time points during therapy with interleukin-2 (IL-2) alone and plus
genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma.


- Evaluate the differences in peripheral blood mononuclear cell gene expression following
high-dose IL-2 with and without genistein and compare to baseline.

- Determine the overall response rate (partial and complete) in patients treated with
these regimens.

- Determine the safety and toxic effects of these regimens in these patients.

- Determine the time to progression in patients treated with these regimens.

OUTLINE: This is a pilot study.

Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and
3 times daily on days 2-5 and 16-19. Patients also receive oral genistein twice daily on
days 10-19.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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 asthma

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)

Outcome Time Frame:

Days 1, 8, 10, 15, 22, and 24 of treatment

Safety Issue:


Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 04V1



Start Date:

November 2005

Completion Date:

December 2014

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • recurrent melanoma
  • stage IV melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma



Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611