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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 cancer cells.

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


Clinical Trial 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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Tumor
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Plasma Cell
  • Neuroblastoma
  • Ovarian Cancer
  • Plasmacytoma
  • Preleukemia
  • Testicular Germ Cell Tumor
  • Testicular Neoplasms
  • Trophoblastic Neoplasms

NCT number NCT00003107
Study type Interventional
Source Indiana University
Contact
Status Completed
Phase Phase 1
Start date October 1997

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