Clinical trial NCT00002621: Interferon Alfa in Treating Children With HIV-Related Cancer
Official title: A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: recurrent childhood acute lymphoblastic leukemia
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
unspecified childhood solid tumor, protocol specific
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
stage I childhood small noncleaved cell lymphoma
stage I childhood large cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage II childhood large cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-11
Enrollment: 8
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete response rate for HIV related malignancies treated with interferon
timeFrame: Length of study
Secondary outcomes:
measure: Event Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Via Christi Regional Medical Center
state: Kansas
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: Hackensack
country: United States
facility: Tomorrows Children's Institute
state: New Jersey
city: Asheville
country: United States
facility: Mission Saint Joseph's Health System
state: North Carolina
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Lackland Air Force Base
country: United States
facility: San Antonio Military Pediatric Cancer and Blood Disorders Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Montreal
country: Canada
facility: McGill University Health Center - Montreal Children's Hospital
state: Quebec
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico School of Medicine Medical Sciences Campus
city: Geneva
country: Switzerland
facility: Clinique de Pediatrie
Study officials:
affiliation: Montreal Children's Hospital at McGill University Health Center
name: V. M. Whitehead, MD
role: STUDY_CHAIR
References: