Full Text View
Tabular View
No Study Results Posted
Related Studies
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
This study has been completed.

First Received on November 9, 2001.   Last Updated on April 1, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
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
Cutaneous Melanoma
Biological: recombinant interferon alfa
Biological: recombinant interleukin-12
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Q 3 months during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: study registration to progression or death ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2001
Study Completion Date: February 2008
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IL-12 followed by IFN-alpha Therapy
Treatment of metastatic malignant melanoma patients with interleukin-12 followed by interferon-alpha.
Biological: recombinant interferon alfa
3 MU sub Q injection on Days 2-6 of each 14 day cycle
Biological: recombinant interleukin-12
300 ng/kg IV bolus on Day 1 of each 14 day cycle

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

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00026143     History of Changes
Other Study ID Numbers: CDR0000068990, U10CA031946, CALGB-500001
Study First Received: November 9, 2001
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Interleukin-12
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
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012