Status:
COMPLETED
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 cell...
Detailed Description
OBJECTIVES: Primary * 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 ...
Eligibility Criteria
Inclusion
- 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 asthma
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00276835
Start Date
November 1 2005
End Date
January 1 2014
Last Update
April 10 2015
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013