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Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: November 9, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026143
  Purpose

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: recombinant interferon alfa
Biological: recombinant interleukin-12
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


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

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the clinical response rate in patients with metastatic malignant melanoma treated with interleukin-12 and interferon alfa.
  • Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression.

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

PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 6-12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cutaneous melanoma

    • Clinically evident distant, metastatic, unresectable regional lymphatic, or extensive in transit recurrent disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Lytic lesions
      • Lesions in a previously irradiated area
  • No brain metastases or other CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 9 g/dL (transfusion or epoetin alfa allowed)
  • No hemolytic anemia

Hepatic:

  • Hepatitis B surface antigen negative

Renal:

  • Not specified

Cardiovascular:

  • No uncontrolled or severe cardiovascular disease

Pulmonary:

  • No pulmonary disease

Other:

  • HIV negative
  • No prior peripheral neuropathy
  • No active or unresolved severe peptic ulcer disease or gastrointestinal bleeding
  • No history of or active autoimmune disease
  • No concurrent infection
  • No diabetes
  • No other major active illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interleukin-12
  • No prior interferon alfa for metastatic disease
  • Prior adjuvant interferon alfa allowed provided patient is disease-free for at least 12 months after last treatment
  • No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-12)

Chemotherapy:

  • At least 3 weeks since prior chemotherapy
  • No more than 1 prior chemotherapy regimen

Endocrine therapy:

  • At least 3 weeks since prior anti-hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026143

  Show 79 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: William E. Carson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068990, CALGB-500001
Study First Received: November 9, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00026143     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Interleukin-12
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Adjuvants, Immunologic
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Interferon Alfa-2a

ClinicalTrials.gov processed this record on November 27, 2009