Clinical trial NCT00090870: PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Official title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2004-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.

Secondary

* Determine duration of response in patients treated with this regimen.
* Determine the tolerance to and toxicity of this regimen in these patients.
* Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma

  * Metastatic disease
* Measurable disease

  * Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

    * Histologic confirmation required if measurable disease is confined to a solitary lesion
  * The following are not considered measurable disease:

    * Bone disease only
    * Pleural or peritoneal metastases
    * CNS lesions
    * Irradiated lesions unless disease progression was documented after prior radiotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL
* No decompensated liver disease

Renal

* Creatinine ≤ 2.0 mg/dL

Immunologic

* No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system
* No history of autoimmune disease
* No autoimmune hepatitis
* No immunosuppressed transplantation recipients

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation
* No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range
* No severe psychiatric condition or disorder, including suicidal ideation or attempt
* No other active malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* More than 4 weeks since prior radiotherapy

Surgery

* Not specified

Primary outcomes:
measure: Response Rate
timeFrame: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Secondary outcomes:
measure: Duration of Response
timeFrame: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
measure: Frequency of Adverse Events Assessed by NCI CTC Version 2
timeFrame: From the first day of treatment until the end of treatment visit, an average of 6 months
measure: Progression-free Survival
timeFrame: From registration until diease progression or death, whichever comes first.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Uzair B. Chaudhary, MD
role: STUDY_CHAIR
affiliation: Medical University of South Carolina, Hollings Cancer Center
name: Gustavo Leone
role: STUDY_CHAIR
References: