Interferon Alfa in Treating Children With HIV-Related Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: recombinant interferon alfa Drug: cytarabine Drug: therapeutic hydrocortisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A PHASE II STUDY OF ALPHA INTERFERON (ALPHA INTERFERON) IN HIV-RELATED MALIGNANCIES |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 1994 |
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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Kansas | |
| Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, New Jersey | |
| Tomorrows Children's Institute | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Mission Saint Joseph's Health System | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Texas | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Canada, Quebec | |
| McGill University Health Center - Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Switzerland | |
| Clinique de Pediatrie | |
| Geneva, Switzerland, 1211 | |
| Study Chair: | V. M. Whitehead, MD | Montreal Children's Hospital at McGill University Health Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002621 History of Changes |
| Other Study ID Numbers: | CDR0000063972, POG-9362 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferon-alpha Interferon Alfa-2a Cytarabine Interferons Cortisol succinate Hydrocortisone acetate |
Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013