Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00504140
First received: July 17, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objectives:

  1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
  2. To determine if IFN alters the plasma pharmacokinetics of etoposide.
  3. To determine the toxicities of IFN and etoposide when administered together.
  4. To determine IFN blood levels following combination therapy.

Condition Intervention Phase
Osteosarcoma
Drug: Etoposide
Drug: Interferon Alpha
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma. [ Time Frame: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks) ] [ Designated as safety issue: No ]
    Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or > decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.


Enrollment: 30
Study Start Date: November 1996
Study Completion Date: March 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon Alpha + Etoposide
Interferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days
Drug: Etoposide
100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
Other Name: VP-16
Drug: Interferon Alpha
5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
Other Names:
  • IFN-
  • Roferon

Detailed Description:

Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks (8 courses). The catheter will remain in place throughout treatment.

Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.

Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.

The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.

During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.

About 37 patients will be treated on the study at M. D. Anderson.

THIS IS AN INVESTIGATIONAL STUDY. IFN- and VP-16 are approved by the U.S. Food and Drug Administration for treating some types of cancer. Their use together against osteosarcoma is investigational.

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.
  2. Age 5-70 years.
  3. Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to 2.
  4. Patients must have measurable disease.
  5. Adequate hematologic, coagulation, renal, and hepatic function.
  6. No chemotherapy, immunotherapy, hormonal therapy or radiation therapy within 3 weeks of study entry.

Exclusion Criteria:

  1. Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
  2. Pregnant or lactating women.
  3. Patients who have had more than one prior biologic response modifier.
  4. Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
  5. Patients of childbearing potential, not practicing adequate contraception.
  6. Significant cardiovascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504140

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Schering-Plough
Investigators
Principal Investigator: Eugenie S. Kleinerman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504140     History of Changes
Other Study ID Numbers: P96-221
Study First Received: July 17, 2007
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Osteosarcoma
Interferon Alpha
IFN-
Roferon
Recombinant Interferon Alpha
Etoposide
VP-16

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Etoposide phosphate
Interferons
Etoposide
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014