Kidney Cancer Clinical Trial

Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer

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 together with interleukin-2 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.

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Full 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 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00100906

Recruitment Status:

Completed

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00100906

Recruitment Status:

Completed

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

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