NCT00026143

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

November 9, 2001

Last Update Submit

June 4, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Up to 2 years

  • PFS

    From registration until time of documented progression of disease or death from any cause, assessed up to 2 years

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: recombinant interleukin-12Biological: recombinant interferon alfaOther: laboratory biomarker analysis

Interventions

recombinant interleukin-12BIOLOGICAL

Given IV

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472
Arm I
recombinant interferon alfaBIOLOGICAL

Given SC

Also known as: Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
  • Patients must have measurable disease; measurable disease is defined as the presence of at least one measurable lesion; if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology; measurable lesions are defined as lesions that can be accurately measured in at least one dimension with the longest diameter \>= 20 mm using conventional techniques or \>= 10 mm with spiral CT scan
  • Lesions that are considered intrinsically non-measurable include the following:
  • Bone lesions;
  • Leptomeningeal disease;
  • Ascites;
  • Pleural/pericardial effusion;
  • Inflammatory breast disease;
  • Lymphangitis cutis/pulmonis;
  • Abdominal masses that are not confirmed and followed by imaging techniques;
  • Lytic lesions;
  • Lesions that are situated in a previously irradiated area
  • No history of peripheral neuropathy, brain metastases or other central nervous system disease
  • No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled
  • No hepatitis BSAg, known HIV disease or other major active illness; patients with risk factors for HIV should be tested; patients with these illnesses are more likely to experience significant side effects from the study treatment
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-12 Subunit p35Interleukin-12Interferon-alphaInterferon Alfa-n3IntronsInterferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • William Carson

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2001

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

July 1, 2004

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)