Interferon Alfa in Treating Children With HIV-Related Cancer

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002621

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

129

Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific	Biological: recombinant interferon alfa	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 1994

Actual Primary Completion Date :

Jul 1, 2002

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alpha interferon (aIFN) treatment See detailed description.	Biological: recombinant interferon alfa Other Names: Intron A Roferon A NSC 377523

Arm

Intervention/Treatment

Experimental: Alpha interferon (aIFN) treatment

See detailed description.

Biological: recombinant interferon alfa

Other Names:

Intron A

Roferon A

NSC 377523

Outcome Measures

Primary Outcome Measures

Complete response rate for HIV related malignancies treated with interferon [Length of study]

Secondary Outcome Measures

Event Free Survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
2	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
3	Tomorrows Children's Institute	Hackensack	New Jersey	United States	07601
4	Mission Saint Joseph's Health System	Asheville	North Carolina	United States	28801
5	Medical City Dallas Hospital	Dallas	Texas	United States	75230
6	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas	United States	78236-5300
7	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811
8	McGill University Health Center - Montreal Children's Hospital	Montreal	Quebec	Canada	H3H 1P3
9	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan		Puerto Rico	00936-5067
10	Clinique de Pediatrie	Geneva		Switzerland	1211