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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Chiron Corporation; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Aldesleukin; Interleukin-2; Tretinoin

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