Clinical Trials Directory

Trials / Completed

CompletedNCT00003107

Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors

A Phase I Trial of Recombinant Human Interleukin-12 After High-Dose Therapy and Autologous Hematopoietic Stem Cell Support

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
Indiana University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who have hematologic cancer or solid tumor.

Detailed description

OBJECTIVES: I. Assess the safety and maximum tolerated dose of interleukin-12 (IL-12) in patients with hematologic malignancies or solid tumors who have undergone high-dose chemotherapy and autologous stem cell transplantation. II. Evaluate the hematologic and immunologic effects of IL-12 in these patients. OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV as a single test dose followed by 2 weeks of rest. Patients then receive IL-12 IV daily for 5 days followed by 16 days of rest for up to 6 courses. Cohorts of 3-5 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrecombinant interleukin-12

Timeline

Start date
1997-10-01
First posted
2004-04-06
Last updated
2014-09-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003107. Inclusion in this directory is not an endorsement.