Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
18 Years
N/A
Both
Kidney Cancer
Trial Information
Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
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
cell cancer.
- Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide
before and after treatment with tretinoin and interleukin-2 in these patients.
Secondary
- Determine the frequency of treatment-related side effects in these patients.
- Determine clinical objective response and progression-free survival of patients treated
with this regimen.
- Correlate DC:ImC ratio with clinical objective response in patients treated with this
regimen.
- Correlate the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin
blood levels in these patients.
OUTLINE: This is a randomized, open-label study. Specimens are stratified according to
patient prognostic factors, tumor bulk, and extent of dendritic cell to circulating immature
cell ratio derangement. Patients are randomized to 1 of 3 tretinoin doses.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 27-36 patients (9-12 per treatment arm) will be accrued for
this study within 2 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment
Outcome Description:
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 cell cancer.
Outcome Time Frame:
1 year, 3 months
Safety Issue:
No
Principal Investigator
Mayer Fishman, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-13920
NCT ID:
NCT00100906
Start Date:
August 2004
Completion Date:
September 2013
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- clear cell renal cell carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
