Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026520
First received: November 9, 2001
Last updated: June 20, 2013
Last verified: April 2003
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: recombinant interferon alfa
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
Study Completion Date: April 2006
Detailed Description:

OBJECTIVES:

  • Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide.
  • Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.

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

PROJECTED ACCRUAL: A total of 35 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 stage IV malignant melanoma

    • Surgically incurable disease
  • Measurable or evaluable disease
  • No brain metastases by CT scan or MRI

    • Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy
  • Must have received 1, and only 1, prior systemic therapy for metastatic disease

    • Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study
  • HIV negative
  • No AIDS or HIV-1-associated complex
  • No other serious illness
  • No serious active infections
  • No sensory neuropathy greater than grade 1
  • No prior seizures or concurrent potential risk factors for the development of seizures
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered
  • No concurrent filgrastim (G-CSF)
  • No other concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered
  • No concurrent hormonal therapy
  • No concurrent systemic steroids (including creams)

Radiotherapy:

  • See Disease Characteristics
  • At least 21 days since prior radiotherapy and recovered
  • Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 21 days since prior surgery for primary or metastatic disease and recovered
  • No concurrent surgery

Other:

  • At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered
  • At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered
  • No other concurrent therapy
  • No other concurrent investigational drugs
  • No concurrent immunosuppressive medications
  • Concurrent antihistamines allowed if no alternative medication available
  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: NCT00026520

  Show 94 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Laura F. Hutchins, MD University of Arkansas
  More Information

Additional Information:
Publications:
Hutchins L, Moon J, Clark J, et al.: Interferon alpha-2b and thalidomide in previously treated patients with disseminated malignant melanoma: SWOG 0026. [Abstract] J Clin Oncol 22 (Suppl 14): A-7527, 716s, 2004.

ClinicalTrials.gov Identifier: NCT00026520     History of Changes
Other Study ID Numbers: CDR0000069046, SWOG-S0026
Study First Received: November 9, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interferon-alpha
Interferons
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014