Clinical trial NCT00561912
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma Renal Cell Cancer Clear Cell Kidney Decitabine Dacogen 5-Aza-Deoxycytidine Interferon Alfa-2b Intron A® RCC
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-10-01; Completion date: 2009-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

* To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.

Secondary Objectives:

* To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in patients with advanced RCC
* To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
* To determine the overall survival times for patients with advanced RCC treated with decitabine and interferon.
* To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.
* To characterize the modulation of cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these results with clinical outcomes.

Detailed description:
THE STUDY DRUGS:

Decitabine is designed to slow tumor growth and may cause death of cancer cells.

Interferon alfa-2B is designed to activate your immune system, which may help keep tumors from growing, and may shrink tumors.

STUDY TREATMENT:

If you are found to be eligible to take part in this study, you will receive decitabine by vein over 1 hour on Days 1-5 of each cycle. A cycle in this study is 28 days long. All treatments with decitabine will take place at M. D. Anderson.

Once you have completed 2 cycles of decitabine (on Day 1 of Cycle 3), you will begin taking interferon alfa-2b twice each day (morning and afternoon) while continuing the same 5-day dosing schedule for decitabine. Interferon alfa-2b will be given as a subcutaneous (just under the skin) injection. It can be given by yourself or a caregiver at home or by your local doctor. You and your caregiver will be taught how to do the injection.

STUDY VISITS:

You will have the following tests/procedures performed during clinic visits.

On Day 1 of each cycle:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any medications or treatments you may be currently receiving.
* You will have a performance status evaluation.
* You will be asked about any side effects you may have experienced since your last visit. You will have blood drawn (about 1 teaspoon) for routine testing.

Beginning in Cycle 3, you will be required to return to the clinic around Day 14 of each cycle to have the following tests:

* You will have blood drawn (about 1 teaspoon each time) once a week for routine tests. If you do not experience severe side effects during Cycles 3 and 4, you will no longer be required to have weekly routine blood testing. Instead, you will return to have routine blood drawn on Day 1 of each cycle. This once-weekly schedule will restart if you experience severe side effects in Cycle 5.
* You will have a CT or MRI scan to check the status of the disease.
* Your vital signs will be measured
* You will be asked about any side effects you may have experienced since your last visit.

LENGTH OF STUDY:

You will continue taking the study drug combination unless the disease gets worse, you develop an illness that does not allow you to continue receiving the study therapy, or you experience any intolerable side effects. If any of these things occur, you will be removed from this study.

This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Interferon alfa-2b is FDA approved and commercially available for the treatment of several types of cancer, such as malignant melanoma, hairy cell leukemia, and non-Hodgkin's lymphoma. Their use together in this study in the treatment of PRC is investigational and authorized for use in research only.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Decitabine 15 mg/m\^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
Interventions: intervention 1: Decitabine intervention 2: Interferon Alfa-2b
Intervention descriptions: intervention 1: 15 mg/m\^2 IV Daily over one hour for 5 days intervention 2: 0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.

Protocol documents: