Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast

Status Completed

Clinical Trial Summary

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 breast cancer cells.

PURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer.

Clinical Trial Description

OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of patients who have not progressed after 6 months of therapy. II. Compare percentage of patients who have not progressed after six months with or without treatment regimen. III. Determine time to progression and overall survival in this patient population after this treatment.

OUTLINE: This is a randomized study. Patients are stratified according to disease free interval from primary diagnosis to first metastases (less than 3 years vs 3 years and longer), estrogen receptor status (positive vs negative), and disease status (complete response, partial response, detectable disease, or stable disease). Patients are randomized to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12 subcutaneously twice a week. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no progression after 1 year, may be followed as needed for new signs or symptoms and survival for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first 6 months, patients may receive interleukin-12 as in arm I. Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for toxicity only until interleukin-12 is discontinued. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00004893
Study type	Interventional
Source	Alliance for Clinical Trials in Oncology
Contact
Status	Completed
Phase	Phase 2
Start date	December 1999
Completion date	February 2002

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms