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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003107
Recruitment Status : Completed
First Posted : April 6, 2004
Last Update Posted : September 10, 2014
National Cancer Institute (NCI)
Information provided by:
Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor Biological: recombinant interleukin-12 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Recombinant Human Interleukin-12 After High-Dose Therapy and Autologous Hematopoietic Stem Cell Support
Study Start Date : October 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven hematologic malignancies or solid tumors Undergone high-dose chemotherapy or chemoradiotherapy with autologous bone marrow and/or peripheral blood stem cell transplantation Confirmation of complete remission is required for acute leukemia No significant CNS disease No clinically significant ascites or pleural effusions Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Platelet count at least 50,000/mm3 (transfusion independent) No clinically significant coagulopathy (unless due to cancer and resolved) Hepatic: Bilirubin no greater than 2 mg/dL SGOT no greater than 2 times upper limit of normal No chronic or acute hepatitis Hepatitis B surface antigen negative Renal: Creatinine no greater than 2 mg/dL No symptomatic hypercalcemia Calcium less than 12 mg/dL Cardiovascular: No uncontrolled angina No arrhythmias requiring drug or device therapy No symptomatic congestive heart failure Pulmonary: No clinically significant pulmonary dysfunction Metabolic: No uncontrolled diabetes mellitus No untreated hyper or hypothyroidism No Cushing's disease Gastrointestinal: No clinically significant gastrointestinal hemorrhages No uncontrolled peptic ulcer disease No history of inflammatory bowel disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious infection requiring IV antibiotics No psychosis No clinically significant autoimmune disease HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic therapy Chemotherapy: See Disease Characteristics Endocrine therapy: At least 3 weeks since prior corticosteroids No concurrent systemic corticosteroids (other than replacement doses) Radiotherapy: See Disease Characteristics Surgery: Not specified Other: No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003107

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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
Sponsors and Collaborators
Indiana University School of Medicine
National Cancer Institute (NCI)
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Study Chair: Michael J. Robertson, MD Indiana University Melvin and Bren Simon Cancer Center
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Responsible Party: Michael Robertson, MD/ Principal Investigator, Indiana University School of Medicine Identifier: NCT00003107    
Other Study ID Numbers: 9708-05; T97-0027
First Posted: April 6, 2004    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by Indiana University:
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
chronic idiopathic myelofibrosis
testicular embryonal carcinoma
Additional relevant MeSH terms:
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Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases