PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00090870
First received: September 7, 2004
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: PEG-interferon alfa-2b
Biological: sargramostim
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Median and progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: April 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090870

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00090870     History of Changes
Other Study ID Numbers: CDR0000378049, MUSC-100614, CELGENE-MUSC-100614, MUSC-HR-10423
Study First Received: September 7, 2004
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
Thalidomide
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014