Interferon Alfa in Treating Children With HIV-Related Cancer

Lymphoma Clinical Trial

Official title:

A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002621
• Other study ID #: 9362
• Secondary ID: POG-9362CDR00000
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 23, 2014
• Start date: December 1994
• Est. completion date: September 2005

Study information

• Verified date: July 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors.

Description:

OBJECTIVES:

• Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa.

• Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.

OUTLINE:

• Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14.

• Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter.

Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol.

PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2005
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven malignancy diagnosed at any time following confirmation of HIV-positivity, including the following:

• Leukemia

• Non-Hodgkin's lymphoma

• CNS lymphoma

• Other solid tumors

• Measurable disease

• Concurrent registration on protocol POG-9182 required

• Confirmed HIV-positive by POG-9182 criteria

• Required biology studies completed

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• Not specified

Life expectancy:

• More than 4 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3 (unless bone marrow involvement present)

Hepatic:

• See Disease Characteristics

• Bilirubin less than 1.5 times normal

• SGPT and SGOT less than 2 times normal (may discuss with Study Coordinator)

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• Adequate cardiac function by echocardiogram/MUGA scan

Other:

• Chronically infected patients must be stable enough to meet life expectancy requirement

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interferon for cancer

• Prior interferon alfa for viral infections (i.e., hepatitis) must be discussed with Study Coordinator

Chemotherapy:

• At least 1 week since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 week since prior radiotherapy

Surgery:

• Not specified

Other:

• Prior antiretroviral therapy allowed

• At least 1 week since prior acute treatment for any serious or life-threatening infection

• No concurrent local treatment unless discussed with the Study Coordinator

• No concurrent acute treatment for any serious or life-threatening infection

• Concurrent antiretroviral therapy allowed

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Biological:
• recombinant interferon alfa

Locations

Country	Name	City	State
Canada	McGill University Health Center - Montreal Children's Hospital	Montreal	Quebec
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
Switzerland	Clinique de Pediatrie	Geneva
United States	Mission Saint Joseph's Health System	Asheville	North Carolina
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Tomorrows Children's Institute	Hackensack	New Jersey
United States	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Via Christi Regional Medical Center	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate for HIV related malignancies treated with interferon		Length of study	No
Secondary	Event Free Survival		1 year	No