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A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

Uzair B. Chaudhary, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000378049

NCT ID:

NCT00090870

Start Date:

April 2002

Completion Date:

March 2010

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425