NCT00504140

Brief Summary

Primary Objectives:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 1996

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

11 years

First QC Date

July 17, 2007

Last Update Submit

August 1, 2012

Conditions

Osteosarcoma

Keywords

OsteosarcomaInterferon AlphaIFN-RoferonRecombinant Interferon AlphaEtoposideVP-16

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.

    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)

Study Arms (1)

Interferon Alpha + Etoposide

EXPERIMENTAL

Interferon Alpha 5x10\^6 mu/m\^2 subcutaneously and Etoposide 100 mg/m\^2 intravenously, both daily for 5 days

Drug: EtoposideDrug: Interferon Alpha

Interventions

EtoposideDRUG

100 mg/m\^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.

Also known as: VP-16
Interferon Alpha + Etoposide
Interferon AlphaDRUG

5x10\^6 mu/m\^2 Subcutaneously Daily for 5 Days

Also known as: IFN-, Roferon
Interferon Alpha + Etoposide

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
  • Pregnant or lactating women.
  • Patients who have had more than one prior biologic response modifier.
  • Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
  • Patients of childbearing potential, not practicing adequate contraception.
  • Significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Osteosarcoma

Interventions

EtoposideInterferon-alphaInterferon alpha-2

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Eugenie S. Kleinerman, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

November 1, 1996

Primary Completion

November 1, 2007

Study Completion

March 1, 2009

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)