Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma

August 1, 2012 updated by: M.D. Anderson Cancer Center

Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • VP-16
Drug: Interferon Alpha
5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
Other Names:
  • Roferon
  • IFN-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Schering-Plough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (ESTIMATE)

July 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P96-221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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