Status:
COMPLETED
Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving tretinoin toge...
Detailed Description
OBJECTIVES: Primary * Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell cancer
- Stage IV disease
- Histology with clear cell component
- Metastatic OR incompletely resected disease
- Non-measurable disease allowed
- Underwent complete or partial nephrectomy more than 90 days ago
- No unresected primary cancer
- No more than 2 of the following adverse factors:
- Hemoglobin \< 10.0 g/dL
- Corrected calcium \> upper limit of normal (ULN)
- Lactic dehydrogenase \> 1.5 times ULN
- Eastern Cooperative Oncology Group (ECOG) performance status 2
- Brain metastasis allowed provided more than 90 days of clinical and radiologic stability after the end of its active treatment
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- See Disease Characteristics
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- See Disease Characteristics
- Serum glutamic oxaloacetic transaminase (SGOT) \< 3 times normal
- Bilirubin \< 2 times normal
- Renal
- See Disease Characteristics
- Creatinine clearance \> 40 mL/min
- Cardiovascular
- None of the following cardiovascular conditions within the past year:
- Uncontrolled hypertension
- Myocardial infarction
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Class II-IV peripheral vascular disease within the past year
- Other clinically significant cardiovascular disease
- Immunologic
- No history of immunodeficiency disease
- No HIV infection
- No ongoing serious infection
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two methods of effective contraception during and for 1 month (for women) or 6 months (for men) after study treatment
- Other prior malignancy allowed provided there is no evidence of active disease
- No other medical contraindication to tretinoin or interleukin-2
- No serious non-healing wound, ulcer, or bone fracture
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 60 days since prior immunotherapy
- Chemotherapy
- At least 60 days since prior cytotoxic chemotherapy
- Endocrine therapy
- See Radiotherapy
- No prior corticosteroids at \> physiologic replacement doses for \> 3 days within the past 90 days
- Concurrent tamoxifen, toremifene, megestrol, or gonadotropin-releasing hormone agonists allowed
- Concurrent inhaled steroids allowed
- Radiotherapy
- More than 7 days since prior external-beam radiotherapy
- No steroid requirement during radiotherapy
- Surgery
- See Disease Characteristics
- At least 30 days since other prior debulking surgery
- Other
- Prior adjuvant therapy for resected, synchronous stage IV disease allowed
- Prior adjuvant therapy allowed
- Study therapy is not to be used as adjuvant therapy for completely resected late (\> 1 year until identification) solitary site of disease metastasis or non-metastatic disease
- No prior participation in this clinical study
- At least 60 days since other prior anticancer drugs
- Concurrent seizure medication allowed
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00100906
Start Date
August 1 2004
End Date
July 1 2013
Last Update
August 16 2013
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497