PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00238329
First received: October 12, 2005
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: PEG-interferon alfa-2b
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Response rate as measured scans and tumor measurements every 8 weeks [ Designated as safety issue: No ]
  • Qualitative and quantitative toxicities at 30 days following study treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
  • Overall survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
  • Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2001
Estimated Study Completion Date: June 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  • Determine progression-free and overall survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma, including any of the following:

    • Cutaneous melanoma
    • Ocular melanoma
    • Mucosal melanoma
    • Unidentified primary tumor
  • Recurrent or metastatic disease
  • Bidimensionally measurable or evaluable disease
  • Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT ≤ 2 times ULN

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • None of the following conditions within the past 3 months:

    • Congestive heart failure
    • Second- or third-degree heart block
    • Myocardial infarction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  • No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
  • No concurrent blood, sperm, or ova donation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy (e.g., interferon) allowed

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy

Surgery

  • At least 28 days since prior surgery

Other

  • No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
  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: NCT00238329

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00238329     History of Changes
Other Study ID Numbers: CDR0000445593, P30CA022453, WSU-C-2257, WSU-HIC-120900M01-FB
Study First Received: October 12, 2005
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent melanoma
stage IV melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
recurrent intraocular melanoma

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal 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

ClinicalTrials.gov processed this record on July 26, 2014