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


Phase 2
5 Years
70 Years
Not Enrolling
Both
Osteosarcoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)

Safety Issue:

No

Principal Investigator

Eugenie S. Kleinerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

P96-221

NCT ID:

NCT00504140

Start Date:

November 1996

Completion Date:

March 2009

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma
  • Interferon Alpha
  • IFN-
  • Roferon
  • Recombinant Interferon Alpha
  • Etoposide
  • VP-16
  • Osteosarcoma

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030